Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 91.
CANCER
Subchapter A. CANCER REGISTRY
25 TAC §§91.1 - 91.12
The Executive Commissioner of the Health and Human Services
Commission (commission) on behalf of the Department of State Health Services
(department) adopts amendments to §§91.1 - 91.12, concerning the
reporting of cancer cases for the recognition, prevention, cure or control
of those diseases, and to facilitate participation in the national program
of cancer registries established by 42 United States Code §§280e
to 280e-4. The amendment to §91.2 is adopted with a change to the proposed
text as published in the April 14, 2006, issue of the
Texas Register
(31 TexReg 3154). Sections 91.1, and 91.3 through 91.12
are adopted without changes, and therefore, the sections will not be republished.
BACKGROUND AND PURPOSE
The amendments will bring rules in line with federal requirements for cancer
case information to be reported to the central cancer registry; update methods
of transmitting case information to the state to reflect current technology;
and, clarify reporting expectations for large cancer caseload facilities and
facilities with highly qualified cancer reporting personnel to improve cancer
reporting efficiency and timeliness. The amendments remove a reference to
a repealed state law regarding medical records privacy to avoid conflicts
with federal law.
Government Code, §2001.039, requires that each state agency review
and consider for readoption each rule adopted by that agency pursuant to the
Government Code, Chapter 2001 (Administrative Procedure Act). Sections 91.1
- 91.12 have been reviewed and the department has determined that reasons
for adopting the sections continue to exist because rules on this subject
are needed.
SECTION-BY-SECTION SUMMARY
The reference to the Texas Board of Health was deleted in §91.1. Amendments
to §91.2, Definitions, add a new definition and clarify other definitions.
Amendments to §91.3(e), Who Reports, Access to Records, and §91.9(d),
Confidentiality and Disclosure, remove the reference to repealed law, Health
and Safety Code, Chapter 181, Medical Records Privacy, §181.101. Amendments
to §91.4(a)(1)(B) clarify language to comply with the national program
of cancer registries. Additional amendments to §91.4(b), Reportable Information,
add; casefinding source; managing physician; and follow-up physician and removes
capability to submit cancer reports manually. Section 91.4(b)(1)(B) adds language
to report the primary payer at the time of diagnosis to the extent that information
is available in the medical record, and additional language to §91.4(b)(2)(B)
adds that reports shall be fully coded. The amendment to §91.5 revises
timeframes for reporting data.
Amendments to §91.6, How to Report, add the requirements for Internet
reporting using acceptable software by large facilities. In §91.6, the
amendments also remove the ability of facilities to submit paper reports and
the ability to transmit cases via modem. Section 91.7(a) and (b) was deleted
to eliminate the submission of paper forms. Amended language to §91.8(b)
clarifies reporting timeframes. Additional language to §91.10(1) states
that the department will provide technical assistance. Section 91.11 revises
references to new agency and data needed for years "1998-2002" instead of
"1992-1995". Section 91.12(b)(3) was deleted to reflect organizational changes
resulting in centralized registry operations. Amended language to §91.12(b)(5)
clarifies who has access to personal medical records.
All of Subchapter A includes updates to names, references and processes
to reflect post-consolidation operations.
COMMENTS
The department, on behalf of the commission, did not receive any public
comments concerning the proposal during the comment period. However, the department
staff on behalf of the commission provided comments and the commission has
reviewed and agrees to the following change that will clarify the definition
of Cancer.
Change: Concerning §91.2(3), the department noted an incorrect inclusion
of the word "nervous" in the definition of Cancer. The text was published
in the April 14, 2006, issue of the
Texas Register
as "benign tumors nervous as required by the national program of cancer
registries." It was recommended that the word "nervous" be deleted to reflect
correct wording and grammar. The amendment language is corrected and now reads
"benign tumors as required by the national program of cancer registries."
LEGAL CERTIFICATION
The Department of State Health Services, General Counsel, Cathy Campbell,
certifies that the rules, as adopted, have been reviewed by legal counsel
and found to be a valid exercise of the agencies' legal authority.
STATUTORY AUTHORITY
The amendments are authorized by Health and Safety Code, §82.005 as
amended, which requires the department to maintain a central data bank of
accurate, precise, and current information to serve as a tool in the early
recognition, prevention, cure and control of cancer; and Government Code, §531.0055,
and Health and Safety Code, §1001.075, which authorize the Executive
Commissioner of the Health and Human Services Commission to adopt rules and
policies necessary for the operation and provision of health and human services
by the department and for the administration of Health and Safety Code, Chapter
1001. Review of the rules implements Government Code, §2001.039.
§91.2.Definitions.
The following words and terms, when used in these sections, shall have
the following meanings, unless the context clearly indicates otherwise.
(1)
Act--The Texas Cancer Incidence Reporting Act, Texas Health
and Safety Code, Chapter 82.
(2)
Branch--Cancer Epidemiology and Surveillance Branch of
the department.
(3)
Cancer--Includes a large group of diseases characterized
by uncontrolled growth and spread of abnormal cells; any condition of tumors
having the properties of anaplasia, invasion, and metastasis; a cellular tumor
the natural course of which is fatal, including intracranial and central nervous
system malignant, borderline, and benign tumors as required by the national
program of cancer registries; and malignant neoplasm, other than non-melanoma
skin cancers such as basal and squamous cell carcinomas.
(4)
Cancer reporting handbook--The branch's manual for cancer
reporters that documents reporting procedures and format.
(5)
Clinical laboratory--An accredited facility in which tests
are performed identifying findings of anatomical changes; specimens are interpreted
and pathological diagnoses are made.
(6)
Department--Department of State Health Services.
(7)
Health care facility--A general or special hospital as
defined by the Health and Safety Code, Chapter 241; an ambulatory surgical
center licensed under the Health and Safety Code, Chapter 243; an institution
licensed under the Health and Safety Code, Chapter 242; or any other facility,
including an outpatient clinic, that provides diagnostic or treatment services
to patients with cancer.
(8)
Health care practitioner--A physician as defined by Occupations
Code, §151.002 or a person who practices dentistry as described by the
Occupations Code, §251.003.
(9)
Personal cancer data--Information that includes items that
may identify an individual.
(10)
Quality assurance--Operational procedures by which the
accuracy, completeness, and timeliness of the information reported to the
department can be determined and verified.
(11)
Report--Information provided to the department that notifies
the appropriate authority of the occupancy of a specific cancer in a person,
including all information required to be provided to the department.
(12)
Research--A systematic investigation, including research
development, testing, and evaluation, designed to develop or contribute to
generalizable knowledge.
(13)
Statistical data--Aggregate presentation of individual
records on cancer cases excluding patient identifying information.
(14)
Texas Cancer Registry--The cancer incidence reporting
system administered by the Cancer Epidemiology and Surveillance Branch.
This agency hereby certifies that the adoption has been
reviewed by legal counsel and found to be a valid exercise of the agency's
legal authority.
Filed with the Office of
the Secretary of State on June 19, 2006.
TRD-200603360
Cathy Campbell
General Counsel
Department of State Health Services
Effective date: July 9, 2006
Proposal publication date: April 14, 2006
For further information, please call: (512) 458-7111 x6972
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