007-40-21 Ark. Code R. § 1

Current through Register Vol. 49, No. 6, June, 2024

Rule 007.40.21-001 - Rules Pertaining to the Arkansas Cancer Registry

SECTION I.AUTHORITY

The following Rules Pertaining to the Arkansas Cancer Registry are duly adopted and promulgated by the Arkansas State Board of Health and implemented by the Arkansas Department of Health ("Department"), pursuant to the authority expressly conferred by the laws of the State of Arkansas, specifically Ark. Code Ann. §§ 20-15-201 - 205.

SECTION II.PURPOSE

The purpose of these rules is to clarify the cancer-reporting responsibilities of medical care professionals, hospitals, laboratories and institutions, pursuant to Arkansas law. In addition, it contains intervention for noncompliance, reinforces the confidentiality requirements, authorizes the exchange of cancer incidence data with other states and for the data to be made available to the public. In carrying out this mandate, the Department's Arkansas Central Cancer Registry ("ACCR") collaborates with the National Cancer Institute, the Centers for Disease Control and Prevention, medical research institutions, national and international cancer surveillance programs designated by the ACCR, the Arkansas Cancer Coalition, and public health agencies. The importance of cancer registration was reinforced by the passage of federal legislation in 1992 ( Public Law 102-515 ) establishing the National Program of Cancer Registries, in which Arkansas participates.

SECTION III.DEFINITIONS

A. "Arkansas Cancer Coalition (ACC)" means the statewide comprehensive cancer control partnership, which is a network of members and organizations that strive to provide an overview of cancer control in Arkansas, strengthen and sustain the cancer control partnership and support network, and direct goals and strategies in the Arkansas Cancer Plan.

B. "Benign neoplasms" means a benign tumor that does not grow in an unlimited, aggressive manner and does not invade surrounding tissues and does not metastasize.

C. "Borderline tumor" means a neoplasm with many histologic criteria of malignancy, but future behavior is uncertain.

D. "Cancer" means cellular abnormalities with widely variable courses, some grow rapidly, others grow slowly, others stop growing completely and some regress.

E. "Casefinding" means a systematic process of locating cases eligible for inclusion in the cancer registry to include but not limited to pathology reports and disease indices.

F. "Casefinding Audit" means a systematic process of reviewing facility based documents and information to ensure that all eligible/reportable cancer cases were identified, abstracted and reported by facilities to the ACCR.

G. "In Situ (in place) cancer" means a cancer that involves only the place in which it began and that has not spread, or invaded and may regress.

H. "Invasive cancer" means a tumor that grows in an uncontrolled manner and invades surrounding tissues and is capable of metastasizing.

I. "New Primary" means a very basic definition is a first time diagnosed cancer

J. "Qualified researcher" means a researcher from a recognized institution, including without limitation an academic, state or federal government, or nonprofit nongovernmental institution, and who is adequately trained about conditions where names and identities of individuals are appropriately protected while conducting research for the purposes of cancer prevention, control, and treatment.

A. "Re-Abstracting (Quality Assurance) Audit" means a systematic process of reviewing specific data items and codes, to help ensure quality and accurate coding is being submitted by facilities to the ACCR.

B. "Registry" means the system for the reporting, collection, and analysis of cancer cases by the Arkansas Department of Health.

C. "Reporting" means the notification furnished to the Department of cases of in situ or invasive neoplasms of the human body, not including squamous cell and basal cell carcinoma of the skin.

SECTION IV.PARTICIPATION IN THE PROGRAM

A. All licensed health care facilities and providers including, but not limited to: hospitals, pathology laboratories, health care practitioners, radiation treatment facilities, specialty clinics (e.g. dermatology, oncology, urology clinics, etc.), surgery centers/clinics, and dental offices shall participate in the program.

B. All participants shall designate specific staff member(s) to be responsible for reporting required cancer data and shall notify the ACCR of the name(s), title, work telephone number and e-mail address of the designated staff member(s).

SECTION V.CANCER CASE REPORTING

A. Reportable Cancer Cases

1. Any newly diagnosed in situ or invasive cancer or reportable benign and borderline conditions as specified by the ACCR. If a patient subsequently develops a new primary cancer, it shall be reported separately. In addition, health care facilities and providers shall furnish follow-up data on each cancer patient when requested.

B. Format for reporting

1. The format for reporting, the required coding guidelines, and the standards for completeness and quality are specified by the ACCR. Text is required for specified variables and shall be adequate to permit quality assurance evaluation of coding decisions.

C. Data Items to be reported

1. The standardized report of cancer shall include as a minimum those data items required by the ACCR. The report of cancer shall include the listed demographic, diagnostic, and treatment data as defined by the ACCR.

D. Deadline for Reporting

1. Reporting shall occur no later than six months after the date of diagnosis of cancer and/or initial treatment of cancer.

E. Failure to Report

1. If a hospital, laboratory, facility or health care practitioner fails to provide the required information in the format or time specified by the ACCR or if the data are of unacceptable quality, personnel from the ACCR staff may enter the facility, or access the information electronically, to abstract the information.

F. Quality Assurance

1. Staff members from the ACCR shall perform periodic quality assurance activities on all reporting facilities. These activities shall include:

a. Casefinding to ensure that all reportable cancer cases have been accessioned; and

b. Reabstracting the records of cancer patients to ensure accurate and complete coding of all data.

2. Reporting facilities shall assist the ACCR staff by providing the necessary casefinding documents, medical records and office space for conducting quality assurance activities.

3. In order to improve the quality of the data, the ACCR or their appointees shall offer training to reporting facility personnel if deemed necessary.

SECTION VI.CONFIDENTIALITY

A. All information reported to the ACCR shall be confidential and shall not be disclosed under any circumstances except:

1. To other state cancer registries or federal organizations with which the Department has data sharing agreements that ensure confidentiality;

2. To Department officials and its agents who are obligated to keep such information confidential; and

3. For Department approved cancer research under specific conditions where names and identities of the individuals are appropriately protected, and when such research is conducted for the purpose of cancer prevention, control and treatment.

B. Protection of Patient Identifying Information Obtained by Special Studies and Other Research Studies.

1. All identifying information such as records of interviews, questionnaires, reports, statements, notes and memoranda that are procured or prepared by employees or agents of the Arkansas Central Cancer Registry shall be used solely for statistical, scientific and medical research purposes and shall be held strictly confidential by the ACCR. This applies also to identifying information procured by any other person, agency, or organization, including public or private colleges and universities acting jointly with the ACCR in connection with special cancer studies and health research investigations.

SECTION VII.RELEASE OF DATA

A. Release of non-identifying information

1. To Federal Agencies: The ACCR is authorized to collaborate with the National Program of Cancer Registries (NPCR), the Centers for Disease Control and Prevention (CDC), and the National Cancer Institute (NCI) to provide cancer incidence statistics and participate in cancer studies.

2. To the Arkansas Department of Health: The ACCR shall work closely with the Arkansas Department of Health in investigating cancer-related issues and in evaluating programs. Because the ACCR data are an integral part of the Arkansas Department of Health cancer prevention and control programs, the use of registry data by public health officials shall be considered an in-house activity. Data required by the Arkansas Department of Health for responding to concerns expressed about threats to the public shall receive priority in determining the order of processing requests.

3. To the general public: Public reports published by the ACCR shall include aggregate, not patient identifying information or facility identifying information. Information that would potentially identify a cancer patient shall not be published.

4. To Others: The ACCR is authorized to collaborate with the North American Association of Central Cancer Registries (NAACCR) to provide cancer incidence statistics and participate in cancer studies.

5. To Qualified Cancer Researchers: The ACCR is authorized to collaborate with the Arkansas Cancer Coalition to provide cancer statistics and participate in cancer studies with qualified researchers.

B. Release of identifying information

1. Identifying information collected from any hospital, laboratory, facility or health care practitioner may be released to qualified persons for the purposes of cancer prevention, control and research, as approved by the Department

2. Actual costs of the data linkage shall be borne by the qualified researcher.

C. Interstate Exchange of Data

1. Because cancer patients may be diagnosed or receive treatment in another state, the ACCR is authorized to sign agreements with other states to acquire cancer data concerning Arkansas residents and, in return, to provide those states with data relating to their residents. Each signatory state shall agree in writing to keep all patient data confidential and privileged as defined in the contract for data exchange.

SECTION VIII.VIOLATIONS AND PENALTIES

Every firm, person, or corporation who violates this rule may be assessed a civil penalty by the Board of Health. The penalty shall not exceed one thousand dollars ($1,000) for each violation. Each day of a continuing violation may be deemed a separate violation for purposes of penalty assessments. However, no single fine levied by the Board shall exceed ten thousand dollars ($10,000).

SECTION IX.EFFECTIVE DATE

The initial effective date of a version of these Rules was March 1, 2012. Any further revisions to these Rules will be effective upon compliance with the Administrative Procedure Act and only after legislative approval.

SECTION X.SEVERABILITY

If any provision of these Rules, or the application thereof to any person or circumstances is held invalid, such invalidity shall not affect other provisions or applications of these Rules which can give effect without the invalid provisions or applications, and to this end the provisions hereto are declared to be severable.

SECTION XI.REPEAL

All Rules and parts of Rules in conflict herewith are hereby repealed.

007.40.21 Ark. Code R. § 001

Adopted by Arkansas Register Volume MMXXI Number 10, Effective 9/27/2021