Current through Register Vol. 49, No. 9, September, 2024
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.
