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CHAPTER II:

HISTORICAL BACKGROUND AND STATUS OF NORTH
AMERICAN STANDARDS

STANDARD-SETTING ORGANIZATIONS AND OTHER STANDARDS DOCUMENTS

Several organizations have played a major role in the development of cancer registry standards. They are listed in alphabetical order.

American Cancer Society

ACS historically has supported the development of standardized cancer classification systems, publishing the first code manual for the morphology of neoplasms in 1951. ACS has long supported the standard-setting programs of ACoS, including the Fundamental Tumor Registry Operations Education Program, the Registry Operations and Data Standards, and the American Joint Committee on Cancer (AJCC).

American College of Surgeons

Since the 1950s, ACoS has taken a leading role in establishing standards for hospital-based cancer programs and the cancer registries that are a part of such programs. Through its accreditation program, the Commission on Cancer (CoC) implements its requirements for case management, registry operation and case inclusion, and data set specifications as published in:

• Cancer Program Standards,²⁷ which presents standards for the full range of cancer program activities, including the registry.

• Standards for Oncology Registry Entry (STORE):² which specifies standards for cases to be included in the registry, data items to be collected, and the codes and coding rules for those items.

CoC requires accredited cancer programs to use the codes and coding instructions published by CoC.

Through the National Cancer Database (NCDB), jointly funded by the ACoS and the American Cancer Society, the CoC provides data quality feedback to accredited cancer programs, software providers, and the general cancer registry community. Hospitals in the accreditation program are required to submit non-confidential registry data to the NCDB. The CoC monitors the quality of data submissions in accordance with existing published standards for accredited programs.

STORE, the Cancer Program Standards, and the NCDB Call for Data announcements, instructions, and technical specifications are available to download at no charge at https://www.facs.org/quality-programs/cancer/ncdb. The CoC maintains an interactive CAnswer Forum Database to answer questions about all cancer-related program and data collection requirements.

American Joint Committee on Cancer

AJCC formulates and publishes systems of tumor classification by anatomic site and histology through use of the Tumor, Node, Metastasis (TNM) staging system. The AJCC cancer staging system is the U.S. standard used by the medical profession to select the most effective treatments and determine prognosis to facilitate the management of cancer care. AJCC is dedicated to the ideal that all cancer cases should be staged, and it publishes the Cancer Staging Manual,⁷ now in its Eighth Edition.

Canadian Council of Cancer Registries

The Canadian Council of Cancer Registries (CCCR) is the standard setting organization in Canada. Established in 1978, the CCCR provides leadership and support to the provincial and territorial cancer registries (PTCR) responsible for collecting information on cancer incidence in Canada. Voting membership of the Council consists of a senior official from each provincial/territorial cancer registry and Statistics Canada. Non-voting members include a representative from the Public Health Agency of Canada (PHAC), the Canadian Partnership Against Cancer (CPAC), the Canadian Cancer Society (CCS), the Chair of the Data Quality Management Committee (DQMC) and the Chair of the Data Use and Publication Committee (DUPC) as well as a hospital based registry. Secretarial support is offered through Statistics Canada.

The primary objectives of the CCCR are to provide direction for data collection and use; provide leadership and support for standard setting and quality management of data; ensure there is consistency with the standards and practices as outlined by the North American Association of Central Cancer Registries and the International Association of Cancer Registries; facilitate liaison and communication with partners; facilitate access to data for surveillance and research and promote the use and dissemination of cancer control information.

The Canadian cancer data set is housed in the Canadian Cancer Registry (CCR) and includes data collected and reported to Statistics Canada by each PTCR. The dynamic patient-based CCR is a database of all Canadian residents who have been diagnosed with cancer in Canada since 1992, replacing the event-based (1969) National Cancer Incidence Reporting System (NCIRS). The CCR provides nationally standardized and comparable longitudinal data to monitor cancer incidence rates by basic demographic characteristics. When linked to other sources of administrative data such as hospitalization and death data, the analytical value of the CCR is maximized as information about surgical treatment and cancer survival can be ascertained.

National Cancer Registrars Association

Chartered in 1974, the National Cancer Registrars Association (NCRA) is a non-profit organization that represents more than 5,800 cancer registry professionals and Certified Tumor Registrars (CTR). Its mission is to serve as the premier education, credentialing, and advocacy resource for cancer data professionals. NCRA actively supports the cancer registry industry at the national level by identifying public policy opportunities that will support the work of registrars and by developing and implementing strategies that directly influence public policy. NCRA also serves as the cancer registrar’s voice at meetings with standard setters, national organizations, and federal agencies and seeks to promote the profession through its public relations and marketing efforts. NCRA’s educational programming includes an annual conference, live workshops and webinars, textbooks, publications, and a variety of online training products and services posted to its Center for Cancer Registry Education. NCRA’s other educational efforts include accrediting formal education programs that are available online and at community colleges throughout the U.S.

Established in 1983, the CTR credential is nationally recognized in the recruitment and retention of cancer registry personnel. NCRA’s certification board—the Council on Certification—develops and administers the CTR exam, which is based on seven domains of practice: casefinding, abstracting/coding, follow-up, data quality assurance, analysis and data usage, registry organization and operations, and cancer program accreditations. To maintain the credential, CTRs are required to complete 20 hours of continuing education every two years. In the past 35 years, over 8,000 individuals have attained the CTR credential.

Learn more about NCRA at www.ncra-usa.org. The Center for Cancer Registry Education can be found at www.CancerRegistryEducation.org and details on the CTR exam are available at www.ctrexam.org.

National Coordinating Council for Cancer Surveillance

Founded in 1995, the National Coordinating Council for Cancer Surveillance (NCCCS) meets semi-annually to coordinate surveillance activities within the United States through communication and collaboration among major national cancer organizations, ensuring that the needs of cancer patients and the communities in which they live are fully served; that scarce resources are maximally used; and that the burden of cancer in the United States is adequately measured and ultimately reduced. NCCCS includes representatives from the Armed Forces Institute of Pathology, ACoS, ACS, AJCC, CDC-NPCR, CDC-NCHS, NCI-SEER, NCI-Applied Research Program, NCRA, and NAACCR. Current priorities for NCCCS include building coordination among cancer incidence surveillance and other cancer surveillance systems; electronic medical records and real-time reporting; improving source information to measure disparity (race, ethnicity, socioeconomic status); non-hospital reporting; and defining a decision process for incidence surveillance expansion, both in the addition of data elements and modification of surveillance systems.

National Program of Cancer Registries

CDC has worked to improve registry data nationwide since 1992, when Congress authorized the establishment of the National Program of Cancer Registries (NPCR) through the Cancer Registries Amendment Act (Public Law 102-515, 42 USC 280e-280e-4).³³ Before NPCR was established, 10 states had no registry, and most states with registries lacked the resources and legislative support they needed to gather complete data. In 1994, CDC first funded 28 states and the Program has since grown to support 50 central cancer registries. As of 2020, CDC has established co-operative agreements with 46 states, the District of Columbia, Puerto Rico, the Pacific Island Jurisdictions, and the U.S. Virgin Islands. CDC works to:

• Assist in planning or enhancing cancer registries.
• Develop model legislation and regulations for programs to increase the viability of registry operations.
• Set standards for data completeness, timeliness, and quality.
• Provide training for registry personnel.
• Help establish computerized reporting and data processing systems.
• Collaborate with other organizations and agencies on cancer surveillance, including ACS, ACoS, CCCR, NCRA, NAACCR, SEER, WHO, and IACR.
• Annually publish, in collaboration with NPCR partners, U.S. Cancer Statistics –  the official federal cancer statistics.
• Provide publicly available national cancer datasets.

CDC contributes substantially to the development of data standards through its financial support of NAACCR, as well as by funding and developing EDITS, a software system that facilitates the coordination of data standards (see Chapter IV). In administering NPCR, CDC requires participating central registries to collect data items that conform to NAACCR standards. NPCR staff also continues to maintain Registry Plus^TM, a suite of publicly accessible free software programs made available by CDC to facilitate the implementation of NPCR. NPCR staff works collaboratively with the cancer registry community to develop standards, based on the NAACCR Volume II data standards, for electronic reporting from pathology laboratories and non-hospital physicians.

To maximize the benefits of state-based cancer registries, CDC uses the NPCR-Cancer Surveillance System (CSS) for receiving, assessing, enhancing, aggregating, and disseminating data from NPCR-funded registries. This system of cancer surveillance provides valuable feedback to improve the quality and usefulness of registry data and monitor the impact of cancer prevention and control programs.

Since 2002 CDC has coordinated with NCI to produce U.S. Cancer Statistics (USCS), the official federal cancer statistics on the entire U.S. population. U.S. Cancer Statistics data are available in multiple data products, including a Data Visualizations tool and public-use databases, which can be accessed at www.cdc.gov/uscs. U.S. Cancer Statistics data can be used to: monitor cancer trends over time; show cancer patterns in various populations and identify high-risk groups; and advance clinical, epidemiological, and health services research. Additional information about NPCR, is available at: www.cdc.gov/cancer/npcr.

North American Association of Central Cancer Registries

The American Association of Central Cancer Registries (AACCR) was established in 1987, and with the addition in 1995 of Canadian registries as members, the name was changed to the North American Association of Central Cancer Registries (NAACCR). Members are population-based cancer registries in the United States and Canada, national cancer and vital statistics organizations in both countries, and other organizations and individuals interested in cancer registration and surveillance. NAACCR is a professional organization that develops and promotes uniform data standards for cancer registration; provides education and training; certifies population-based registries for high-quality data; evaluates, aggregates, and publishes data from central cancer registries; and promotes the use of cancer surveillance data and systems for cancer control and epidemiologic research, public health programs, and patient care to reduce the burden of cancer in North America.

Surveillance Epidemiology and End Results Program

NCI's SEER Program has collected standardized data to measure progress in cancer prevention and control for more than 40 years. Established by a federal mandate--the National Cancer Act of 1971--the SEER Program is a sequel to two earlier NCI programs: the End Results Group (1956-72) and the Third National Cancer Survey (1969-71).

Seven population-based registries have provided data continuously since the SEER Program began in 1973: the States of Connecticut, Iowa, New Mexico, Utah, and Hawaii; and the Metropolitan Areas of Detroit and San Francisco-Oakland. In 1974-75, the regions of Seattle-Puget Sound and Metropolitan Atlanta were added. These areas, plus the rural Georgia region added in 1978, cover about 9.5 percent of the U.S. population, followed in 1980 by the addition of American Indians residing in Arizona. In 1992, the SEER Program added two additional regions in California--Los Angeles and San Jose-Monterey--bringing coverage of the U.S. population to 14 percent. In order to increase coverage of the American Indian/Alaska Native populations, SEER has included data from the Alaska Native Tumor Registry since 1984. These regions were selected for their epidemiologically significant population subgroups and, in fact, over-sample minority populations in the United States. In 2001, four states were added--Kentucky, Louisiana, New Jersey, and the remainder of California--resulting in coverage of about 26 percent of the U.S. population. In 2010, greater Georgia joined the SEER program, completing coverage of the state of Georgia and bringing SEER coverage of the U.S. to 28 percent of the population. Idaho, Massachusetts, and New York joined SEER in 2018 to bring current day SEER coverage to 35 percent of the US population. NCI shares funding of these five states with the Centers for Disease Control and Prevention.

The purpose of the SEER Program, as stated in the National Cancer Act legislation, is to collect, analyze, and disseminate data useful in the prevention, diagnosis, and treatment of cancer. The goals of the Program are to:

• Collect complete and accurate data on all cancers diagnosed among residents of geographic areas covered by SEER cancer registries.
• Conduct a continual quality control and quality improvement program to ensure the collection of high quality data.
• Periodically report on the cancer burden as it relates to cancer incidence and mortality, and to patient survival overall and in selected segments of the population.
• Identify unusual changes and differences in the patterns of occurrence of specific forms of cancer in population subgroups defined by geographic, demographic, and social characteristics.
• Describe temporal changes in cancer incidence, mortality, extent of disease at diagnosis (stage), therapy, and patient survival as they may relate to the impact of cancer prevention and control interventions.
• Monitor the occurrence of possible iatrogenic cancers, i.e., cancers that are caused by cancer therapy.
• Collaborate with other organizations on cancer surveillance activities, including CDC's National Program of Cancer Registries and NAACCR.
• Serve as a research resource to the NCI providing for the conduct of studies that address issues dealing with cancer prevention and control as well as program and registry operations.
• Provide analytic resources to the general research community including an annual data file, and software to facilitate the analysis of the database.
• Provide training materials and web-based training resources to the cancer registry community.

These goals illustrate that the aim of the SEER Program is providing cancer surveillance over time. As a result, changes in standards are carefully considered for their impact both on future data and compatibility with previous data.

Participating registries are required to submit data in a standard format using standardized definitions and codes described in the current edition of the SEER Program Coding and Staging Manual.³

Standardized edits, developed by SEER and shared with participating registries, are applied to data submissions, and the results are returned to the participating registries.

SEER Program publications relating to data standards (https://seer.cancer.gov/tools/codingmanuals/index.html) include:

• The SEER Program Coding and Staging Manual.³ This manual includes comprehensive codes, instructions, and coding guidelines for the data elements required by SEER.
• The Hematopoietic and Lymphoid Neoplasm Case Reportability and Coding Manual and Database provide a standardized reference for the collection of data on these complex neoplasms.
• The 2007 Multiple Primary and Histology Coding Rules provide site-specific instructions for determining the number of primaries and coding histology.
  
• The 2018 Solid Tumor Rules replaces the previously posted 2018 Solid Tumor Manual and should be used for coding cases diagnosed January 1, 2018, and forward.
• SEER*Rx an interactive antineoplastic drug database that is updated on a regular basis.
• SEER casefinding lists are regularly updated to include codes from the latest editions of ICD-9 and ICD-10.
• ICD-O-3 SEER Site/Histology Validation List is a standard cancer registry reference for valid site and histology combinations.
• SEER Summary Staging Manual 2018¹² Published in 2018, it is the standard for summary stage for cases diagnosed January 1, 2018, and forward.

Publications are available electronically and may be downloaded and printed without charge. Historical Staging and Coding Manuals are available at https://seer.cancer.gov/tools/codingmanuals/historical.html

Additional instructional resources are available on the SEER website (http://seer.cancer.gov/registrars/).

• SEER maintains a database of registrar questions and answers, the SEER Inquiry System (SINQ). Designated staff members from SEER registries can submit questions to SINQ. The questions are answered by the Quality Improvement Team at NCI SEER. Outside experts are consulted when necessary. The questions and answers are available to the entire registry community. http://www.seer.cancer.gov/seerinquiry/index.php.
• For questions not found in SINQ, SEER offers a service called "Ask a SEER Registrar." http://www.seer.cancer.gov/registrars/contact.html. Anyone may submit a question using the electronic form on the SEER website. The submitter will receive an answer via email from the Quality Improvement Team at NCI SEER. Selected questions are then entered into SINQ to make the information available to all.
• SEER*Educate provides hands-on coding and abstracting training for those new to the Cancer Registry field and for experienced registrars. All modules are available free of charge and NCRA Continuing Education is available for some modules. https://educate.fhcrc.org/LandingPage.aspx
  
• The SEER Training Website offers basic instruction for those new to the field, as well as a refresher for those who have more experience. http://training.seer.cancer.gov/

World Health Organization

The World Health Organization (WHO), an agency of the United Nations, is responsible for publishing and maintaining the international standard for diagnosis coding systems. Selected publications include:

• International Classification of Diseases (ICD-9, the Ninth Revision), as modified by the Health Care Financing Administration¹⁵
• International Statistical Classification of Diseases and Related Health Problems (ICD-10, the 10th Revision)¹⁴
• International Classification of Diseases for Oncology ^{16, 17}

These publications are world-standard diagnosis coding systems.

ICD-9 was adapted for use in the United States as the Clinical Modification of ICD-9 (ICD-9-CM).¹⁵ ICD-10¹⁴ was implemented for coding causes of death on death certificates in the United States effective January 1, 1999 and is the current standard for coding medical record diagnoses in health information management departments in U.S. health care facilities since October 2015.

The Second Edition of ICD-O¹⁷ became the standard for coding cancer diagnoses in the United States in 1992. An extensive revision of the morphology codes, especially the Lymphoma and Leukemia Section, was field-tested for the 1999 and 2000 diagnosis years, and the Third Edition of ICD-O¹⁶ was implemented for 2001 diagnoses.

WHO published an updated ICD-O-3 in 2013. Refer to the 2014 Guidelines for ICD-O-3 Update Implementation for instructions, http://www.naaccr.org/LinkClick.aspx?fileticket=u7d3sB71t5w%3d&tabid=126&mid=466

WHO publications are sold through the following agency in the United States:

STYLUS PUBLISHING, LLC 22883 Quicksilver Dr. Herndon, VA 20172-0605

Tel: 1-800-232-0223 / 703-661-1581 Fax: 703-661-1501 Email: [email protected] Web site: http://www.Styluspub.com

HISTORICAL BACKGROUND OF STANDARDS COORDINATION

Because the various standard-setting organizations use their data for different purposes, some data elements had different meanings, depending on the organization using the data. A long history of cooperation has been evident among organizations interested in cancer data to resolve the discrepancies between organizations in their interpretation of data elements.

The earliest standard setters were CoC and SEER. The End Results Group, predecessor of SEER, published coding rules and guidelines as early as the 1950s; CoC published its first data collection manual, the Supplement on the Tumor Registry, in conjunction with its Cancer Program Manual 1981. At that time, hospital-based cancer registries often used CoC's recommended codes and coding rules, and SEER central registries used those of the SEER Program. The two systems were not always in agreement. As a result, CoC and SEER began working together in the early 1980s to make the codes and definitions in their manuals consistent.

CoC and SEER attempted to define one common set of data item definitions, field lengths, and codes for use by both SEER registries and hospital-based registries. By 1988, the collaboration resulted in the publication of both CoC's Data Acquisition Manual and the SEER Program Code Manual, with data items and codes in substantial agreement. Having more congruent data sets allowed for easier data sharing and data comparisons, especially with the advent of personal computers that were sufficiently powerful to analyze large amounts of cancer data. This achievement helped set precedents for cooperation in data management, and maintaining congruence whenever possible has continued to be a top priority for these two groups.

During the same period, the California Cancer Registry was developing a statewide automated system that allowed facilities to report electronically to the state registry system. One region in California was a SEER registry at that time, and a large number of hospitals maintained CoC-accredited programs. To facilitate implementation of standards within its program, the California Cancer Registry requested that SEER and CoC establish a formal committee to pursue data standardization and requested membership on this committee.

The function of that committee was transferred to NAACCR's Uniform Data Standards Committee [now the Uniform Data Standards Work Group (UDSWG)] when it was established in 1987. Membership was expanded to include all of the major standard-setting organizations and representation from registry software vendors and central registries. This Work Group has made enormous progress toward standardization. A major success occurred when all of the participating groups agreed to implement the Second Edition of ICD-O simultaneously for tumors diagnosed in 1992 and later. In 1993, NAACCR convened a multidisciplinary conference to address the issue of collecting data on pre-invasive cervical neoplasia, resulting in specific recommendations for member registries to cease collection of cervical carcinoma in situ. UDSWG provides a national forum to discuss data issues and reach consensus on data standards. Given the extensive effort required to maintain uniform standards, in 2000, a subsidiary of Uniform Data Standards Committee, the Volume II Work Group (now the Volume II Task Force), was formed to focus on the annual updates, revisions, and additions to compendiums of national standards.

CDC added another strong voice for standardization. CDC requires that the registries in 46 states, the District of Columbia, Puerto Rico, the Pacific Island Jurisdictions, and the U.S. Virgin Islands funded by NPCR use standard data items and codes. CDC is a sponsoring member of NAACCR and has participated in committee activities of NAACCR. CDC provides quality control activities for participants in NPCR and has facilitated the setting of standards and encouraged their adoption. The EDITS project described in Chapter IV is an example of the innovative approach CDC has supported.

At the time of this revision to Volume II, the major organizations agree in principle that their data standards will be consistent wherever possible. There are, however, areas where agreement has not been reached. These are discussed in detail in Chapter V.

Despite the progress made toward standardization and the near-universal agreement that standardization is desirable, much remains to be done. Implementation of existing standards is not uniform, and implementation of changes in standards is not always synchronized. SEER and CoC will continue to publish separate coding manuals on different update schedules. Standardized data edits must be updated, maintained, and used by all registries.

In Canada, cancer registries at the provincial and territorial level joined together with Statistics Canada, a national agency, to form the Canadian Council of Cancer Registries. This process started in 1986 and led to the development of common national standards for the Canadian Cancer Registry, which were implemented with a reference date of January 1, 1992. The Data Quality Management Committee, which reports to the Council, is responsible for making recommendations to set national standards, and will review and monitor data quality and resolve any inconsistencies in procedures, coding, or other activities affecting data comparability.

NAACCR hopes that documenting existing standards, recommending standards where they do not yet exist, and publishing the results in a concise and authoritative form will enable registries and software providers to move forward in achieving comparable data that can be more widely used.

Schedule of Revisions to NAACCR Standards Documents

In 2000, the NAACCR Board of Directors established a Standards Implementation Task Force to review the timeline for changes to data standards and to recommend guidelines for a new timeline that would meet the needs of the standard-setting organizations, central cancer registries, vendors, and reporting facilities. The Standards Implementation Task Force developed guidelines for major changes to be implemented on a 3-year cycle, with minor changes published in an update of the current version of Volume II. The Cancer Registration Steering Committee (CRSC) was established in 2005 to provide regular communication among leaders of NAACCR and its sponsoring member organizations to facilitate coordination and promote consensus in the development and implementation of major data items, standards, and procedures related to cancer registration.

In 2011, the CRSC charged the Change Management Work Group with updating the 2003 Implementation Guidelines to meet the needs of the cancer surveillance community. The Change Management Work Group suggested a flexible process where changes are implemented on a two-year cycle, year one for implementation and year two for evaluation. However, external factors such as legislation or policy-setting at the executive level of standard setting organizations may necessitate more frequent change that would not exceed a frequency of one time per year. The Work Group also recommended the creation of the Change Management Board to manage all aspects of changes impacting hospital and central cancer registries. This process was implemented in 2013.

In 2013, the Uniform Data Standards Work Group decided that the Volume II version would concur with the year of implementation starting in 2014. For example, Volume II, Version 14 was implemented January 2014.

In 2018, the Change Management Board was restructured to the Mid-Level Tactical Group (MLTG) to coordinate and communicate among the cancer surveillance community the development and implementation of changes to standards and procedures.

All NAACCR members are encouraged to present suggestions or comments on proposed changes to the standards to the Mid-Level Tactical Group. The NAACCR website, https://www.naaccr.org/data-standards-data-dictionary/#changerequest, provides the forms for proposing additions and/or revisions.

Table 1. Record Layout Table With References.

Bolded text indicates changes from previous version.
* Either the date of diagnosis or year first seen for this cancer may have been used by some standard setters. Refer to the Data Dictionary or to the standard setter reference manuals for clarification of date requirements.
** Refer to http://www.cancerstaging.org/cstage/ for Collaborative Stage version information.