Part 1.
TEXAS DEPARTMENT OF HEALTH
Chapter 37.
MATERNAL AND INFANT HEALTH SERVICES
Subchapter Q. REPORTING OF ELEVATED LEVELS OF CHILDHOOD LEAD
25 TAC §§37.331 - 37.336
The Texas Department of Health (department) adopts amendments
to §§37.331-37.336, concerning childhood lead reporting without
changes to the proposed text as published in the December 6, 2002, issue of
the
Texas Register
(27 TexReg 11388).
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 37.331-37.336
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist; however changes were necessary as described
in this preamble.
The amendments change the reporting level from ten micrograms per deciliter
of lead to reporting of all blood lead levels, clarify when to report, change
reporting of blood lead levels to 40 micrograms per deciliter immediately
to the department to a specified phone number, and clarify that race and ethnicity
are reported separately.
The department published a Notice of Intention to Review for §§37.331-37.336
in regards to Government Code, §2001.039 in the
Texas Register
on April 28, 2002 (25 TexReg 3799). No comments were
received in regards to the publication of the notice.
There were no comments received on the proposed rules during the comment
period.
The amendments are adopted under Health and Safety Code, §88.003,
which authorizes the board of health (board) to adopt rules relating to the
reporting of childhood blood lead levels; Health and Safety Code, §12.001,
which provides the board with the authority to adopt rules for its procedure
and for the performance of each duty imposed by law on the board, the department,
or the commissioner of health; and implements Government Code, §2001.039.
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 May 9, 2003.
TRD-200302896
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: June 1, 2003
Proposal publication date: December 6, 2002
For further information, please call: (512) 458-7236
25 TAC §37.350
The Texas Department of Health (department) adopts an amendment
to §37.350, concerning the School Health Advisory Committee (committee).
The section is adopted without changes to the proposed text as published in
the March 14, 2003, issue of the
Texas Register
(28
TexReg 2218), and the section will not be republished.
The committee has provided assistance to the Texas Board of Health (board)
in establishing a leadership role for the department in the support for and
delivery of school health services. The committee is established under the
Health and Safety Code, §11.016, which allows the board to establish
advisory committees. The committee is subject to Government Code, Chapter
2110, concerning state agency advisory committees.
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). The department
has reviewed §37.350 and has determined that reasons for adopting the
section continue to exist; however, changes were necessary as described in
this preamble.
The department published a Notice of Intention to Review §37.350 in
the
Texas Register
on April 28, 2000, (25
TexReg 3799). No comments were received due to publication of this notice.
In 1993, the Texas Legislature passed Senate Bill 383 (now codified in
the Government Code, Chapter 2110), which requires that each state agency
adopt rules on advisory committees. The rules must state the purpose of the
committee, describe the tasks of the committee, describe the manner in which
the committee will report to the agency, and establish a date on which the
committee will be automatically abolished unless the governing body of the
agency affirmatively votes to continue the committee's existence.
In 1999, the board established a rule relating to the School Health Advisory
Committee. The rule states that the committee will automatically be abolished
on June 1, 2003. The board has now reviewed and evaluated the committee and
has determined that the committee should continue in existence until June
1, 2007.
This section amends provisions relating to the operation of the committee.
Specifically, language is revised to: continue the committee until June 1,
2007; specify that the committee appoints its presiding and assistant presiding
officers; include additional requirements regarding statements by members;
and clarify the components that the committee must include in an annual report
to the board.
No public comments were received during the comment period for the rule.
The amendment is adopted under Health and Safety Code, §12.001,
which provides the board with the authority to adopt rules for the performance
of every duty imposed by law on the board, the department, and the commissioner;
Government Code, §2110.005, which requires the department to adopt rules
stating the purpose and tasks of its advisory committees; and implements Government
Code, §2001.039.
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 May 8, 2003.
TRD-200302865
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 28, 2003
Proposal publication date: March 14, 2003
For further information, please call: (512) 458-7236
The Texas Department of Health (TDH) adopts amendments to §§97.3
and 97.178, concerning reporting requirements for communicable diseases to
TDH. Section 97.3 is adopted with changes to the proposed text as published
in the January 31, 2003, issue of the
Texas Register
(28 TexReg 821). Section 98.178 is adopted without changes and will
not be republished.
The amended sections list the information that persons are required to
report to TDH. The program reviewed the rule to ensure that covered entities
under the Health Insurance Portability and Accountability Act of 1996 (HIPAA)
would continue to report the same information they currently report after
the federal HIPAA privacy standards (45 Code of Federal Regulations (CFR),
Parts 160 and 164) became effective on April 14, 2003. The amended sections
reflect changes to the rules that were required to ensure there will be no
change in the information reported under these sections, and to further ensure
that HIPAA covered reporting entities will comply with the letter and the
spirit of the HIPAA privacy standards.
The HIPAA privacy standards contain sections that allow HIPAA covered entities
to use and disclose protected health information (PHI), which is individually
identifiable health information, without the authorization of the individual,
if the use and disclosure is required by law or rule, the use and disclosure
complies with the law or rule and is limited to the requirements of the law
or rule (45 CFR §164.512(a), and for public health activities (45 CFR §164.512(b)).
To ensure that all TDH rules meet the standards established in these sections,
TDH conducted a review of TDH rules and the information that is actually received
under the authority of the rules. This review was done to ensure there would
be no interruption of information reported to TDH, and to ensure that persons
required to report under the rules would not be confused or uncertain whether
they were in compliance with the HIPAA privacy standards.
The amended sections correct any discrepancies between the rules and the
information TDH currently receives. The amended sections make no change in
the information a person is currently required to report to TDH. These amendments
to the sections ensure that persons required to report will have continuing
authority to disclose PHI to TDH after the implementation date of the federal
privacy standards.
No public comments were received on the proposed amendments during the
public comment period. However, TDH is making the following change due to
a staff comment to add a reportable disease.
Concerning §97.3(a)(2)(A), "Severe Acute Respiratory Syndrome" ("SARS")
was added to the list of reportable diseases in this section. Though SARS
is reportable under existing §97.3(a)(2)(B) as an "outbreak, exotic disease
or unusual group expression", TDH has amended the list to clarify and make
SARS explicitly reportable.
Subchapter A. CONTROL OF COMMUNICABLE DISEASES
25 TAC §97.3
The amendment is adopted under the authority of the Health
and Safety Code, §81.041, which provides the Board of Health (board)
the right to identify each communicable disease or health condition that shall
be reported; Health and Safety Code, §81.004, which allows the board
to adopt rules necessary for the effective administration of Chapter 81; and
Health and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner.
§97.3.What Condition To Report and What Isolates To Report of Submit.
(a)
Humans.
(1)
Identification of notifiable conditions.
(A)
The most current edition of the Texas Department of Health's
(department) publication titled "Identification, Confirmation, and Reporting
of Notifiable Conditions" shall be reported under these sections based on
a specific diagnosis, test procedure, and/or confirmatory test. Copies are
available upon request to the Materials Acquisition and Management Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756. Copies
are filed in the Infectious Disease Epidemiology and Surveillance Division,
Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756 and
are available for public inspection during regular working hours.
(B)
Repetitive test results from the same patient do not need
to be reported except those for mycobacterial infections.
(2)
Notifiable conditions or isolates.
(A)
Confirmed and suspected human cases of the following diseases/infections
are reportable: acquired immune deficiency syndrome (AIDS); amebiasis; anthrax;
botulism-adult and infant; brucellosis; campylobacteriosis; chancroid; chickenpox
(varicella);
Chlamydia trachomatis
infection;
Creutzfeldt-Jakob disease (CJD); cryptosporidiosis; cyclosporiasis; dengue;
diphtheria; ehrlichiosis; encephalitis (specify etiology);
Escherichia coli
, enterohemorrhagic infection; gonorrhea; Hansen's
disease (leprosy);
Haemophilus influenzae
type
b infection, invasive; hantavirus infection; hemolytic uremic syndrome (HUS);
hepatitis A, B, D, E, and unspecified (acute); hepatitis C (newly diagnosed
infection, effective 1/1/00); hepatitis B, (chronic) identified prenatally
or at delivery as described in §97.135 of this title (relating to Serologic
Testing during Pregnancy and Delivery; human immunodeficiency virus (HIV)
infection; legionellosis; listeriosis; Lyme disease; malaria; measles (rubeola);
meningitis (specify type); meningococcal infection, invasive; mumps; pertussis;
plague; poliomyelitis, acute paralytic; Q fever; rabies; relapsing fever;
rubella (including congenital); salmonellosis, including typhoid fever; shigellosis;
smallpox; spotted fever group rickettsioses (such as Rocky Mountain spotted
fever); streptococcal disease: invasive group A, invasive group B, or invasive
(B)
In addition to individual case reports, any outbreak, exotic
disease, or unusual group expression of disease which may be of public health
concern should be reported by the most expeditious means.
(C)
The following organisms shall be reported:
Enterococcus
species; vancomycin resistant
Enterococcus
species; vancomycin resistant
Staphylococcus aureus
; vancomycin resistant coagulase negative
(3)
Minimal reportable information requirements. The minimal
information that shall be reported for each disease is as follows:
(A)
AIDS, chancroid,
Chlamydia trachomatis
infection, gonorrhea, HIV infection, and syphilis shall be reported
in accordance with §§97.132-97.135 of this title (relating to Sexually
Transmitted Diseases, including AIDS and HIV infection);
(B)
for tuberculosis disease - complete name, date of birth,
physical address and county of residence, information on which diagnosis was
based or suspected. In addition, if known, radiographic or diagnostic imaging
results and date(s); all information necessary to complete the most recent
versions of forms TB 400 A & B (Report of Case and Patient Services),
TB 340 (Report of Contacts) and TB 341 (Continuation of Report of Contacts);
laboratory results used to guide prescribing, monitoring or modifying antibiotic
treatment regimens for tuberculosis to include, but not limited to, liver
function studies, renal function studies, and serum drug levels; pathology
reports related to diagnostic evaluations of tuberculosis; reports of imaging
or radiographic studies; records of hospital or outpatient care to include,
but not limited to, histories and physical examinations, discharge summaries
and progress notes; records of medication administration to include, but not
limited to, directly observed therapy (DOT) records, and drug toxicity and
monitoring records; a listing of other patient medications to evaluate the
potential for drug-drug interactions; and copies of court documents related
to court ordered management of tuberculosis.
(C)
for contacts to a known case of tuberculosis - complete
name; date of birth; physical address; county of residence; and all information
necessary to complete the most recent versions of forms TB 400 A & B (Report
of Case and Patient Services), TB 340 (Report of Contacts), and TB 341 (Continuation
of Report of Contacts);
(D)
for other persons identified with latent TB infection -
complete name; date of birth; physical address and county of residence; and
all information necessary to complete the most recent versions of forms TB
400 A & B (Report of Case and Patient Services);
(E)
for hepatitis B, (chronic and acute) identified prenatally
or at delivery - mother's name, address, telephone number, age, date of birth,
sex, race and ethnicity, preferred language, hepatitis B laboratory test results;
estimated delivery date or date and time of birth; name and phone number of
delivery hospital or planned delivery hospital; name of infant; name, phone
number, and address of medical provider for infant; date, time, formulation,
dose, manufacturer, and lot number of hepatitis B vaccine and hepatitis B
immune globulin administered to infant;
(F)
for chickenpox - name, date of birth, sex, race and ethnicity,
address, date of onset, and varicella vaccination history;
(G)
for all other notifiable conditions listed in paragraph
(2)(A) of this subsection - name, address, telephone number, age, date of
birth, sex, race and ethnicity, disease, type of diagnosis, date of onset,
and physician name, address, and telephone number;
(H)
for all isolates of
Enterococcus
species and all isolates of
Streptococcus
pneumoniae
regardless of resistance patterns - numeric totals at least
quarterly;
(I)
for vancomycin resistant
Enterococcus
species; penicillin resistant
Streptococcus
pneumoniae
; vancomycin resistant
Staphylococcus
aureus
; vancomycin resistant coagulase negative
Staphylococcus
species, - name, city of submitter, date of birth or
age, sex, anatomic site of culture, and date of culture; and
(J)
for Hansen's disease - name; date of birth; sex; race and
ethnicity; social security number; disease type; place of birth; address;
telephone number; date entered Texas; date entered U.S.; education/employment;
insurance status; location and inclusive dates of residence outside U.S.;
date of onset and history prior to diagnosis; date of initial biopsy and result;
date initial drugs prescribed and name of drugs; name, date of birth and relationship
of household contacts; and name, address, and telephone number of physician.
(4)
Diseases requiring submission of cultures. For all
(5)
Laboratory reports. Reports from laboratories shall include
name, patient identification number, address, telephone number, age, date
of birth, sex, race and ethnicity, specimen submitter name, address, and phone
number, specimen type, date specimen collected, disease test and test result,
normal test values, date of test report, and physician name and telephone
number.
(b)
Animals.
(1)
Clinically diagnosed or laboratory-confirmed animal cases
of the following diseases are reportable: anthrax, arboviral encephalitis,
(2)
The minimal information that shall be reported for each
disease includes species and number of animals affected, disease or condition,
name and phone number of the veterinarian or other person in attendance, and
the animal(s) owner's name, address, and phone number. Other information may
be required as part of an investigation in accordance with Texas Health and
Safety Code, §81.061.
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 May 9, 2003.
TRD-200302917
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 29, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
25 TAC §97.178
The amendment is adopted under the authority of the Health
and Safety Code, §81.041, which provides the Board of Health (board)
the right to identify each communicable disease or health condition that shall
be reported; Health and Safety Code, §81.004, which allows the board
to adopt rules necessary for the effective administration of Chapter 81; and
Health and Safety Code, §12.001, which provides the board with the authority
to adopt rules for the performance of every duty imposed by law on the board,
the department, and the commissioner.
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 May 9, 2003.
TRD-200302918
Susan K. Steeg
General Counsel
Texas Department of Health
Effective date: May 29, 2003
Proposal publication date: January 31, 2003
For further information, please call: (512) 458-7236
Subchapter B. DONATION OF UNUSED DRUGS
Subchapter R. SCHOOL HEALTH ADVISORY COMMITTEE
Chapter 97.
COMMUNICABLE DISEASES
Subchapter H. TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES
Chapter 229.
FOOD AND DRUG