College of American Pathologists
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  Optional vs. required and more—putting protocols into practice


CAP Today




February 2012
Feature Story

Thomas P. Baker, MD

The CAP cancer protocols are a set of reporting protocols for the most commonly reported cancers. Sixty-five such protocols are available now on the CAP Web site. Multidisciplinary teams of subject matter experts developed the protocols under the direction of the CAP Cancer Committee, and each one was designed to meet the American College of Surgeons Commission on Cancer requirements for reporting cancers. Additionally, the protocols closely mirror changes in reporting in the American Joint Committee on Cancer (AJCC) Staging Manual that is updated periodically.

Each protocol consists of two important items: the cancer checklist and the reference information or explanatory section. The checklist consists of a set of required and optional data elements using standardized report format and terminology. The checklist is constructed in a synoptic format. The goal is to move pathologists away from narrative formats for reporting to improve completeness of reporting and to ensure that each data element is easily identifiable within the body of the pathology report. The reference or explanatory information section for each protocol is an important tool for the pathologist that discusses such items as margin assessment, determination of tumor size, and criteria for grading.

Updating protocols and making protocols more user-friendly is an ongoing process. The CAP continues to use multidisciplinary teams of subject matter experts to update protocols and provides a period of field testing for new and updated protocols, and it recently introduced a public comment period for all protocol updates. This opportunity for comment from practicing surgical pathologists will ensure that end-user and practitioner input is carefully considered in the process. The goal with end-user input is not only to develop appropriate protocols with pertinent data but also to reflect the needs of the organizations using the protocols.

As protocols are being updated, the CAP is focusing on strength of evidence to determine which elements should be required for reporting cancers. The CAP is using the evidence hierarchy of the National Health and Medicine Council to evaluate and help determine what should be required. As protocols are reviewed and updated, previously required data elements may be downgraded to optional data elements and vice versa based on the strength of evidence in the current literature.

There are several practical points to consider when incorporating the protocols into practice.

 Decisions made by a health care organization regarding the use of cancer protocols should be multidisciplinary. As pathologists, our customers are clinicians from various specialties, tumor registrars, and other providers and facilities outside of our respective institutions. The reports we generate should reflect the needs of our customers. An organization’s cancer committee or tumor board is an ideal group to provide substantial input and to vet the final template that pathologists use for cancer reporting.

 The pathology report must, at a minimum, include the required data elements (and their response, that is, “paired diagnostic parameters”) and should be in a synoptic format. Each required data element (and its corresponding response) must be displayed on a separate line, with some exceptions, or in a tabular format that allows for visual separation. The exceptions to the requirement for data elements to be on separate lines are as follows: Specimen, laterality, and procedure may be on the same line; margin status may be on one line (though margins must still be explicitly listed as outlined in the cancer protocols); and pathologic staging (pTNM) elements can be on one line. Any required data element that is “not present” or “not applicable” still needs to be included in the report and reported as such (for example, lymph-vascular invasion: not present).

 Including optional data elements as a part of the standard report is an organizational decision. Health care organizations can choose whether to include optional data elements in the report. In addition, they don’t necessarily have to report optional elements in a standardized way using the synoptic format; however, doing so will allow for standardization of the reporting format and terminology for the organization and improve ease of data collection.

 The requirement for synoptic reporting doesn’t preclude pathologists from using the narrative format elsewhere. In addition, the synoptic report of required elements does not necessarily have to be in the diagnosis field of the pathology report; it may instead be in the comment field or in a separate section. However, all of the required data elements must be together in one location and must be reported in a synoptic fashion. Once again, though, the organization should make this decision and it should be one that best reflects the organization’s needs.

 When using the synoptic format, organizations can choose to put the required data elements in any order and to use any font style, bolding, indentation, capitalization, or spacing they deem appropriate to better highlight or identify pertinent findings and to achieve visual separation. Required data elements (and the corresponding response, for example, tumor size: 5.0 cm) must be on separate lines or in a format that achieves visual separation. To avoid confusion, pathologists should use the terminology for reporting required elements outlined in the cancer checklists. Any report that does not include the required element and response on the same line is not considered synoptic and does not meet the synoptic format requirements.

 Required and optional elements can be combined into one report or broken up into separate reports based on the organization’s needs. An example of this is reporting of ancillary molecular data and prognostic markers. Some organizations may find it advantageous to report these findings in separate reports.

 With a few exceptions, the cancer checklists aren’t required to be used for biopsies; rather, they were designed for reporting of definitive resection specimens. There are circumstances in which definitive nonsurgical treatment is based on biopsy results, and in these cases the cancer protocol should be used. In addition, many organizations find that consistency in terminology is important when reporting on biopsy specimens and will use a portion of the cancer checklist reporting format in this process.

 The CAP provides an electronic version of the checklists found in its cancer protocols. These electronic cancer checklists (eCC) can be integrated into laboratory information systems. The eCC templates are released in XML format and include regular updates that help to ensure the content is up to date. These templates contain additional information (metadata) to aid implementers in promoting consistent presentation and interoperability of the cancer checklists. A licensed vendor converts the eCC XML into a computerized data entry form, enabling pathologists to capture the clinically relevant structured data of the cancer checklists. eCC implementations are helpful not only in producing standardized diagnostic reports but also in querying data elements and collecting data for research and cancer registry abstraction.

The essential elements of the eCC templates are encoded with SNOMED-CT and ICD-O3 for cancer reporting purposes. eCC data elements will be translated, using new tools the CDC is developing, into discrete codes used by the National Program of Cancer Registries (NPCR) and Surveillance Epidemiology and End Results (SEER). These processes are vital for building the next generation of cancer surveillance and research programs.

 Other tools are available with the cancer protocols that can help an organization streamline and standardize reporting of tumors. As noted earlier, each protocol has attached explanatory notes that can be used to help develop standardized specimen grossing and quality assurance protocols and to reduce interobserver variability in diagnosing and reporting cancers. The CAP recently introduced work aids for several of its protocols that provide a quick reference guide to the key points of the checklists and explanatory notes. These can be used at the microscope and grossing bench to facilitate diagnosis.

Dr. Baker, a member of the CAP Cancer Committee, is interim director, The Joint Pathology Center, Joint Task Force National Capital Region Medical, Bethesda, Md. He is a colonel in the U.S. Army.