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  CAP Cancer Protocols Frequently Asked Questions

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Updated February 10, 2010

The College of American Pathologists produces cancer protocols as a resource to pathologists to aid in effectively reporting surgical pathology findings necessary to provide quality patient care. The protocols consist of cancer case summaries (checklists) accompanied by background documentation. The background documentation includes detailed explanatory notes and references; it is presented for information only. The American College of Surgeons Commission on Cancer (ACS CoC) has recognized the value of the CAP cancer protocols in caring for cancer patients. Starting January 1, 2004, it mandated that pathologists at CoC-approved cancer programs include the scientifically validated or regularly used data elements of the protocols in their surgical pathology reports on cancer specimens.

Please read the important information below about the CAP cancer protocols.

The College of American Pathologists produces cancer protocols as a resource to pathologists to aid in effectively reporting surgical pathology findings necessary to provide quality patient care. The protocols consist of cancer case summaries (checklists) accompanied by background documentation. The background documentation includes detailed outlines, explanatory notes, and references, and it is presented to you for information only. The American College of Surgeons Commission on Cancer (ACS CoC) has recognized the value of the CAP cancer protocols in caring for cancer patients. Starting January 1, 2004, it mandated that pathologists at CoC-approved cancer programs include the scientifically validated or regularly used data elements of the protocols in their surgical pathology reports on cancer specimens.

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 revision date appears near the top of the title page of current protocols.

The College of American Pathologists posted a complete set of revised Cancer Protocols on the CAP website on October 9, 2009, in conjunction with the publication of the seventh edition of the AJCC Cancer Staging Manual.

Pathologists will be encouraged to begin using the new CAP protocols in their clinical reports beginning January 1, 2010.

The CAP recognizes that full implementation by some institutions and laboratory informatics software vendors may require a period of months. CAP plans to recognize a 7 month period of overlap in which either the previous version or the new version may be used. For cancer reports issued on or after August 1, 2010, the new version must be used and reliance on the previous version will no longer be considered acceptable.

For CAP Laboratory Accreditation Program (LAP) accredited laboratories inspected in 2011, only reports from the last quarter of 2010 will be audited by the inspector for compliance with the protocols. This approach will ensure that laboratories inspected in 2011 are evaluated for use of the new version of the CAP protocols.

There are scheduled content releases and updates of the CAP electronic Cancer Checklists (CAP eCC).
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How can I comment on the protocols?

Cancer checklist users are invited and encouraged to comment on the protocols. You may provide feedback by clicking the “Comment” button on the checklist index page. All feedback will be forwarded to the CAP Cancer Committee for its consideration.
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How can I get copies of the protocols?

CAP cancer protocols are now available without charge and can be downloaded from the CAP website. A printed version also is available for purchase. Print an order form from the web page or call CAP Customer Service at 1-800-323-4040 option 1#.

The free download authorization does not extend to reproduction or other use of any substantial portion of these protocols for commercial purposes.

For commercial use of the protocols, contact SNOMED Terminology Solutions. Information on obtaining the CAP eCC is available on the SNOMED Terminology Solutions website.
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When are the protocols revised?

In October 2009, a major revision to the protocols was posted to the CAP website, with an effective date of January 2010. This revision reflects the new American Joint Committee on Cancer (AJCC) Cancer Staging Manual, 7th edition, and the most recent WHO tumor classification systems. As part of this revision, the Cancer Committee has made the protocols more consistent and streamlined.

The CAP’s Cancer Committee and the CAP Cancer Protocol Review Panels are charged with developing new protocols and revising the existing CAP Cancer Protocols on a routine basis. New or significantly revised protocols will continue to be published in Archives of Pathology & Laboratory Medicine.

There are scheduled content releases and updates of the CAP electronic Cancer Checklists (CAP eCC).
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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 CAP protocol may be useful for re-excision specimens, the CAP Cancer Protocols are primarily designed for the definitive initial pathology reporting of cancer specimens. The exceptions to this rule are the protocols for melanoma and Merkel cell carcinoma of the skin, which should be used for re-excision specimens.
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Are there circumstances where a template is recommended for diagnostic needle biopsies?

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.
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Should pathologic stage and template be used for non-invasive carcinomas, i.e. carcinoma-in-situ?

No, with the exception of breast ductal carcinoma in situ (DCIS), which has a separate Cancer Protocols.
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Are there CAP Cancer Protocols for benign tumors such as meningioma?

With the exception of the Brain/Spinal cord protocol, not at this time.
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What does the American College of Surgeons mandate?

Beginning January 1, 2004, the American College of Surgeons Commission on Cancer mandated new standards through its approvals program. New ACS CoC standards have been published and are available through the ACS CoC. COC Standard 4.6 requires that pathologists at CoC-approved cancer programs include all scientifically validated data elements (SVDE) in their surgical pathology reports for each site and specimen. These data elements mandated by the ACS CoC are not exclusive of any other data, but are the minimum requirement for inclusion in the pathology report.

Not all elements of each checklist are scientifically and peer validated or regularly used in patient care; therefore, some elements are not required as part of the ACS mandate. Elements that are not scientifically validated or regularly used in patient care are marked with an asterisk on the protocols. Although the asterisked elements are not yet fully validated or regularly used, they may be clinically important and are, therefore, included in the protocols as suggested elements of the pathology report.

In 2009 the COC revised its Standard 4.6 to award “commendation” beginning in 2010 for laboratories that include a synopsis of the scientifically validated data element in their reports. This synoptic format will improve the usefulness of pathology reports and has been shown to improve the completeness of cancer reports. The CAP developed a list of specific features that define synoptic reporting format:

  1. Data is displayed as the required checklist item (SVDE) followed by its answer (response), e.g. “Tumor Size: 5.5 cm”.
  2. Each diagnostic parameter pair (checklist SVDE: response) is listed on a separate line.
  3. The synopsis can appear in the diagnosis section of the pathology report, at the end of the report or in a separate section, but all SVDE and responses must be listed together in one location.
  4. Additional items (not required for the CAP checklist) may be included in the synopsis but all required SVDE must be present.
  5. Narrative style comments are permitted in addition to, but are not a substitute for the synoptic reporting. Narrative style comments are commonly used for clinical history, gross descriptions and microscopic descriptions.

The CAP has developed examples of synoptic reporting to assist laboratories in developing a synoptic reporting system for their laboratory information system.
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Does the CAP provide additional information to help me use the cancer protocols?

Yes. Each checklist is accompanied by detailed background documentation in support of the checklist elements. The background documentation includes detailed outlines, explanatory notes, and references. It provides highly useful information about the meaning of various data elements. When indicated, the background documentation elucidates how to translate the pathologist’s macroscopic and microscopic findings into the checklist data item. The ACS CoC mandate does not require use of the background documentation. It is presented to you for information only.

Additionally, the CAP eCC provide the CAP cancer protocols encoded on an item for item basis with SNOMED CT in three formats for standardized capture, retrieval and transmission of essential cancer data with a structured report. This subset is used with the SNOMED CT Concepts file to isolate the concepts for the protocols. It can be used for automated upload to a database or file system, can be used for SNOMED-based data entry/storage/retrieval, or to view this portion of SNOMED through subset-enabled software.
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What does the mandate mean?

In order to comply with the ACS mandate, cancer programs will be expected to show that 90 percent of pathology reports include all scientifically validated or regularly used elements of the appropriate protocols.
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How will compliance be determined?

Through the ACS CoC approvals program, cancer programs are surveyed every three years by a physician surveyor who is specially trained to evaluate compliance with all of the standards that are required for approval. Use of the elements of the CAP cancer protocols is one of the 36 standards evaluated during a survey. The surveyor will randomly sample 25 medical records and review pathology reports in these records. The sample will be based upon the five major cancer sites seen by the cancer program during the previous year.
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What if we don’t meet the standard?

If fewer than 90 percent of all cancer reports randomly sampled during your CoC survey include all required scientifically validated or regularly used data elements, you may receive one deficiency.

  • A full three-year approval is granted to a program if all standards are met and no deficiencies are found.
  • A three-year approval with contingency is granted with one to seven deficiencies.

Please note that a program with one to nine deficiencies is allowed 12 months to document changes for administrative review in order to receive full approval.

If a program fails to meet eight or more standards, it will receive non-approval. These programs are encouraged to improve their performance and may reapply.
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What if we’re going through the approvals process for the first time?

If your program is going through the approvals process for the first time and the program is deficient in one standard, deferred status may be granted. Programs granted deferred status have 12 months to document compliance, at which time full approval may be granted. If deficiencies are not resolved within 12 months, the program must reapply for consultation and survey.
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