TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 1. MISCELLANEOUS PROVISIONS

SUBCHAPTER V. [AUTOLOGOUS] ADULT STEM CELLS

25 TAC §1.462

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes an amendment to §1.462, concerning Informed Consent for Investigational Stem Cell Treatment.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with House Bill (H.B.) 3148, 86th Legislature, Regular Session, 2019, which amended Texas Health and Safety Code, §1003.054(c) to require the Executive Commissioner of HHSC, by rule, to adopt an informed consent form that must be signed by an eligible patient before receiving an investigational stem cell treatment. The Executive Commissioner delegated the rule amendment and development of the informed consent form to DSHS. H.B. 3148 requires the informed consent form to provide notice that DSHS administers provisions relating to the administration and oversight of investigational stem cell treatment to certain patients.

Before this proposed amendment, Texas Health and Safety Code, Chapter 1003, did not require DSHS to adopt an informed consent form. Under the current §1.462, physicians are required to provide a written informed consent to the eligible patient. The proposed amendment and informed consent form help ensure that eligible patients are informed about the potential risks and hazards of investigational stem cells treatments not approved for general use by the United States Food and Drug Administration.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §1.462 requires an eligible patient to sign a DSHS informed consent form before receiving a voluntary investigational stem cell treatment.

Proposed amendment to subsection (a) adopts the DSHS written informed consent form for use by physicians administering and patients receiving investigational stem cell treatments. It also announces that the informed consent form is available on the DSHS website. This amendment replaces current subsection (a) requiring the physician to provide the written consent, which must meet or exceed the requirements found in 45 CFR §46.116.

Proposed amendment to subsection (b) requires the physician to obtain additional written informed consent required to comply with other laws or rules established by Texas Health and Safety Code, Chapter 1003. This subsection is necessary to ensure patients receive complete information about risks and hazards specific to their treatment. DSHS is unable to produce a comprehensive form applicable to all investigational stem cell treatments, or a form that can remain current with treatments at various stages of research or clinical trials. Current subsection (b) is deleted with this proposed amendment. It requires the patient to sign the informed consent form. This language is considered redundant, as a signature is required in the proposed DSHS informed consent form.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rule will be in effect:

(1) the proposed rule will not create or eliminate a government program;

(2) implementation of the proposed rule will not affect the number of DSHS employee positions;

(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;

(4) the proposed rule will not affect fees paid to DSHS;

(5) the proposed rule will not create a new rule;

(6) the proposed rule will not expand, limit, or repeal existing rule;

(7) the proposed rule will not change the number of individuals subject to the rule; and

(8) the proposed rule will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard, Chief Financial Officer, has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

The rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.

LOCAL EMPLOYMENT IMPACT

The proposed rule will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045, does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas, does not impose a cost on regulated persons, and is necessary to implement legislation that does not specifically state that §2001.0045 applies to the rule.

PUBLIC BENEFIT AND COSTS

Dr. Manda Hall, Associate Commissioner, has determined that for each year of the first five years the rule is in effect, the public benefit will be that eligible patients receiving a voluntary investigational stem cell treatment will be informed about the potential risks and hazards of treatments not approved for general use by the United States Food and Drug Administration. Patients will have the opportunity to ask questions about their condition, alternative forms of treatment, risks of non-treatment, the procedures to be used, and have sufficient information to give informed consent.

Donna Sheppard, Chief Financial Officer, has also determined that for the first five years the rule is in effect there are no anticipated economic costs to persons who are required to comply with the proposed rule because it only requires patients to sign an informed consent form.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4900 North Lamar Boulevard, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhsc.state.tx.us.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule DSHS-20R014" in the subject line.

STATUTORY AUTHORITY

The amendment is authorized by Texas Health and Safety Code, §1003.054, which authorizes the Executive Commissioner of HHSC to adopt rules requiring an informed consent form that must be signed by an eligible patient before receiving an investigational stem cell treatment. The amendment is also authorized by Texas Government Code, §531.0055 and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by DSHS, and for the administration of Texas Health and Safety Code, Chapter 1001.

The amendment implements Texas Health and Safety Code, Chapters 1001 and 1003 and Texas Government Code, §531.0055.

§1.462.Informed Consent for Investigational Stem Cell Treatment.

(a) Pursuant to Texas Health and Safety Code, §1003.054(c), the Department of State Health Services adopts a written informed consent form for use by physicians administering and patients receiving investigational stem cell treatment under Texas Health and Safety Code, Chapter 1003, Subchapter B. The informed consent form is available on the Department of State Health Services website at www.dshs.texas.gov/chronic/.

[(a) A physician administering an investigational stem cell treatment under this subchapter shall provide a written informed consent to the eligible patient. The written informed consent must meet or exceed the requirements found in 45 CFR §46.116.]

(b) The physician shall obtain any additional written informed consent required to comply with other laws or rules established by Texas Health and Safety Code, Chapter 1003.

[(b) The patient must sign the informed consent form. If the patient is a minor or lacks the mental capacity to provide informed consent, a parent, guardian, or conservator, shall sign the informed consent form.]

(c) The informed consent form must be maintained in the patient's medical record.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on August 28, 2020.

TRD-202003572

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: October 11, 2020

For further information, please call: (512) 939-7575


CHAPTER 97. COMMUNICABLE DISEASES

SUBCHAPTER A. CONTROL OF COMMUNICABLE DISEASES

25 TAC §97.3, §97.4

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §97.3, concerning What Condition to Report and What Isolates to Report or Submit, and §97.4, concerning When and How to Report a Condition or Isolate.

BACKGROUND AND PURPOSE

The purpose of the amendments is to clarify the conditions and diseases that must be reported; clarify the minimal reportable information requirements for the conditions and diseases; and adjust the list of reportable diseases to include diseases and conditions of concern to public health. The amendments comply with guidance from the Centers for Disease Control and Prevention regarding surveillance for reportable conditions, and allow DSHS to conduct more relevant and efficient disease surveillance. The amendments comply with Texas Health and Safety Code, Chapter 81, which requires DSHS to identify each communicable disease or health condition which is reportable under the chapter.

The proposal is also being revised to comply with Texas Government Code, §2001.039, which requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Texas Government Code, Chapter 2001 (Administrative Procedure Act). Sections 97.3 and 97.4 have been reviewed and DSHS has determined that the rules should continue to exist because rules on this subject are needed.

SECTION-BY-SECTION SUMMARY

The amendment to §97.3(a)(2)(A) adds "Candida auris" and "tick-borne relapsing fever" to the notifiable conditions list, and removes "multidrug-resistant Acinetobacter (MDR-A)." The amendment removes "invasive Group A Streptococcus," and "invasive Group B Streptococcus" and updates the term "streptococcal disease: invasive group A, invasive group B, or invasive Streptococcus pneumoniae" to "Streptococcus pneumoniae, invasive." The amendment removes "amebiasis" from the list of notifiable conditions (amebic meningitis and encephalitis will remain).

The amendment to §97.3(a)(3)(D) spells out "tuberculosis" for consistency.

The amendment to §97.3(a)(3)(F), §97.3(a)(3)(I), and §97.3(a)(5) adds "or practitioner" for consistency to be more inclusive of reporting entities.

The amendment to §97.3(a)(4) adds "Candida auris" to the list of diseases requiring submission of cultures.

The amendment to §97.4(a)(2) removes "multidrug resistant Acinetobacter (MDR-A) species" and adds "syphilis infection in pregnant females" and "Candida auris" to the list of notifiable conditions that shall be reported within one working day of identification as a suspected case.

The amendment to §97.4(a)(5)(B) adds the word "Texas" to "Health and Safety Code" to clarify and standardize the reference to the statute.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the sections will be in effect, enforcing or administering the rules do not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will not create new rules;

(6) the proposed rules will not expand, limit, or repeal existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will not be an adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not apply to small or micro-businesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas; and the rules do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Ms. Imelda Garcia, Associate Commissioner, Laboratory and Infectious Disease Services Division, has determined that for each year of the first five years that the rules are in effect, the public benefit will impact the people of Texas whose risk of illness is decreased by the early detection and control or prevention of infectious diseases in the community.

Donna Sheppard has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules.

REGULATORY ANALYSIS

DSHS has determined that this proposal is not a "major environmental rule" as defined by Texas Government Code, §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code, §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4900 North Lamar Boulevard, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhsc.state.tx.us.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted.

STATUTORY AUTHORITY

The proposed amendments are authorized by Texas Health and Safety Code, §81.004, which authorizes rules necessary for the effective administration of the Communicable Disease Prevention and Control Act; and §81.041, which requires a rule to prescribe criteria that constitute exposure to reportable diseases; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters within DSHS jurisdiction. Review of the sections implements Texas Government Code, §2001.039.

The amendments will implement Texas Health and Safety Code, Chapters 81 and 1001; and Texas Government Code, Chapter 531.

§97.3.What Condition to Report and What Isolates to Report or Submit.

(a) Humans.

(1) Identification of notifiable conditions.

(A) A summary list of notifiable conditions and reporting time frames is published on the Department of State Health Services web site at http://www.dshs.state.tx.us/idcu/investigation/conditions/. Copies are filed in the Emerging and Acute Infectious Disease Branch, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756.

(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;] amebic meningitis and encephalitis; anaplasmosis; ancylostomiasis; anthrax; arboviral infections including, but not limited to, those caused by California serogroup virus, chikungunya virus, dengue virus, Eastern equine encephalitis (EEE) virus, St. Louis encephalitis (SLE) virus, Western equine encephalitis (WEE) virus, yellow fever virus, West Nile (WN) virus, and Zika virus; ascariasis; babesiosis; botulism, adult and infant; brucellosis; campylobacteriosis; Candida auris; carbapenem resistant Enterobacteriaceae (CRE); Chagas disease; chancroid; chickenpox (varicella); Chlamydia trachomatis infection; cryptosporidiosis; cyclosporiasis; diphtheria; echinococcosis; ehrlichiosis; fascioliasis; gonorrhea; Haemophilus influenzae, invasive; Hansen's disease (leprosy); hantavirus infection; hemolytic uremic syndrome (HUS); hepatitis A, acute hepatitis B infection, hepatitis B acquired perinatally (child), any hepatitis B infection identified prenatally or at delivery (mother), acute hepatitis C infection, and acute hepatitis E infection; human immunodeficiency virus (HIV) infection; influenza-associated pediatric mortality; legionellosis; leishmaniasis; listeriosis; Lyme disease; malaria; measles (rubeola); meningococcal infection, invasive; [multidrug-resistant Acinetobacter (MDR-A); ] mumps; novel coronavirus; novel influenza; paragonimiasis; pertussis; plague; poliomyelitis, acute paralytic; poliovirus infection, non-paralytic; prion diseases, such as Creutzfeldt-Jakob disease (CJD); Q fever; rabies; rubella (including congenital); salmonellosis, including typhoid fever; Shiga toxin-producing Escherichia coli infection; shigellosis; smallpox; spotted fever group rickettsioses (such as Rocky Mountain spotted fever); streptococcal disease: [invasive group A, invasive group B, or invasive] Streptococcus pneumoniae, invasive; syphilis; Taenia solium and undifferentiated Taenia infections, including cysticercosis; tetanus; tick-borne relapsing fever; trichinosis; trichuriasis; tuberculosis (Mycobacterium tuberculosis complex); tuberculosis infection; tularemia; typhus; vancomycin-intermediate Staphylococcus aureus (VISA); vancomycin-resistant Staphylococcus aureus (VRSA); Vibrio infection, including cholera (specify species); viral hemorrhagic fever; and yersiniosis.

(B) In addition to individual case reports, any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern should be reported by the most expeditious means.

(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 Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV));

(B) for tuberculosis disease - complete name, date of birth, physical address and county of residence, country of origin, 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 department reporting forms: Report of Case and Patient Services, Report of Follow-up and Treatment for Contacts to TB Cases and Suspects; and Report of Verified Case of Tuberculosis; 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; evaluation and disposition; and all information necessary to complete the most recent versions of department reporting forms: Report of Follow-up and Treatment for Contacts to TB Cases and Suspects; and Report of Case and Patient Services;

(D) for other persons identified with tuberculosis [TB] infection - complete name; date of birth; physical address and county of residence; country of origin; diagnostic information; treatment information; medical and population risks; and all information necessary to complete the most recent versions of department reporting form: 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 hepatitis A, B, C, and E - name, address, telephone number, age, date of birth, sex, race and ethnicity, disease, diagnostic indicators (diagnostic lab results, including all positive and negative hepatitis panel results, liver function tests, and symptoms), date of onset, pregnancy status, and physician or practitioner name, address, and telephone number;

(G) for hepatitis B, perinatal infection - name of infant; date of birth; sex; race; ethnicity; 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, hepatitis B laboratory test results;

(H) for chickenpox - name, date of birth, sex, race and ethnicity, address, date of onset, and varicella vaccination history;

(I) for Hansen's disease - name; date of birth; sex; race and ethnicity; 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; disease type i.e., tuberculoid, borderline and lepromatous; 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 or practitioner;

(J) for novel influenza investigations occurring during an influenza pandemic--minimal reportable information on individual cases, a subset of cases or aggregate data will be specified by the department;

(K) 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, diagnostic indicators (diagnostic lab results, specimen source, test type, and clinical indicators), date of onset, and physician or practitioner name, address, and telephone number; and

(L) other information may be required as part of an investigation in accordance with Texas Health and Safety Code, §81.061.

(4) Diseases requiring submission of cultures. For all anthrax (Bacillus anthracis); botulism, adult and infant (Clostridium botulinum); brucellosis (Brucella species); Candida auris; diphtheria (Corynebacteria diphtheria from any site); all Haemophilus influenzae, invasive, in children under five years old (Haemophilus influenzae from normally sterile sites); listeriosis (Listeria monocytogenes); meningococcal infection, invasive (Neisseria meningitidis from normally sterile sites or purpuric lesions); plague (Yersinia pestis); salmonellosis, including typhoid fever (Salmonella species); Shiga toxin-producing Escherichia coli infection (E.coli O157:H7, isolates or specimens from cases where Shiga toxin activity is demonstrated); Staphylococcus aureus with a vancomycin MIC greater than 2 µg/mL; all Streptococcus pneumoniae, invasive, in children under five years old (Streptococcus pneumoniae from normally sterile sites); tuberculosis (Mycobacterium tuberculosis complex); tularemia (Francisella tularensis); and vibriosis (Vibrio species) - pure cultures (or specimens as indicated in this paragraph) shall be submitted accompanied by a current department Specimen Submission Form.

(5) Laboratory reports. Reports from laboratories shall include patient name, 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 range; date of test report; and physician or practitioner name and telephone number.

(b) Animals.

(1) Clinically diagnosed or laboratory-confirmed animal cases of the following diseases are reportable: anthrax, arboviral encephalitis, tuberculosis (Mycobacterium tuberculosis complex) in animals other than those housed in research facilities, and plague. Also, all non-negative rabies tests performed on animals from Texas at laboratories located outside of Texas shall be reported; all non-negative rabies tests performed in Texas will be reported by the laboratory conducting the testing. 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.

(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.

§97.4.When and How to Report a Condition or Isolate.

(a) Humans.

(1) The following notifiable conditions are public health emergencies and suspect cases shall be reported immediately by phone to the local health authority or the appropriate Department of State Health Services regional epidemiology office: anthrax; botulism; diphtheria; measles (rubeola); meningococcal infection, invasive; novel coronavirus; novel influenza; poliomyelitis, acute paralytic; plague; rabies; smallpox; tularemia; vancomycin-intermediate Staphylococcus aureus (VISA); vancomycin-resistant Staphylococcus aureus (VRSA); viral hemorrhagic fever; yellow fever; and any outbreak, exotic disease, or unusual group expression of disease that may be of public health concern.

(2) The following notifiable conditions shall be reported by fax or phone within one working day of identification as a suspected case: brucellosis; Candida auris; carbapenem resistant Enterobacteriaceae (CRE); hepatitis A, acute; hepatitis B, perinatal infection; influenza-associated pediatric mortality; [multidrug-resistant Acinetobacter (MDR-A) species;] mumps; pertussis; poliovirus infection, non-paralytic; Q fever; rubella (including congenital); syphilis infection in pregnant females; tuberculosis (Mycobacterium tuberculosis complex); and Vibrio infection (including cholera).

(3) AIDS, chancroid, Chlamydia trachomatis infection, gonorrhea, HIV infection, and syphilis shall be reported in accordance with Subchapter F of this chapter (relating to Sexually Transmitted Diseases Including Acquired Immune Deficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV)).

(4) Tuberculosis antibiotic susceptibility results should be reported by laboratories no later than one week after they first become available.

(5) For all other notifiable conditions not listed in paragraphs (1) - (4) of this subsection, reports of disease shall be made no later than one week after a case or suspected case is identified.

(A) Transmittal may be by telephone, fax, mail, courier, or electronic transmission.

(i) If by mail or courier, the reports shall be on a form provided by the department and placed in a sealed envelope addressed to the attention of the appropriate receiving source and marked "Confidential."

(ii) Any electronic transmission of the reports must provide at least the same degree of protection against unauthorized disclosure as those of mail or courier transmittal, be by express written agreement with the receiving agency, utilize a format prescribed by the receiving agency, and be validated as accurate.

(B) A health information exchange (HIE) organization as defined by Texas Health and Safety Code, §182.151, may transmit reports on behalf of providers required to report in §97.2(a) - (d) of this title (relating to Who Shall Report) in accordance with Texas Health and Safety Code, Chapter 182, Subchapter D. Health Information Exchanges, and all other state and federal law as follows:

(i) The receiving agency has published message standards.

(ii) A method of secure transmission has been established between the HIE and the receiving agency and transmissions have been tested with the receiving agency and established as meeting the data exchange standards and conveying information accurately.

(iii) Reporting by the HIE has been requested and authorized by the appropriate health care provider, practitioner, physician, facility, clinical laboratory, or other person who is required to report health-related information.

(iv) HIE reports may be made in addition to but shall not replace reports listed in paragraphs (1) - (2) of this subsection.

(6) All diseases requiring submission of cultures in §97.3(a)(4) of this title (relating to What Condition to Report and What Isolates to Report or Submit) shall be submitted as they become available.

(b) Animals. Reportable conditions affecting animals shall be reported within one working day following the diagnosis.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on August 28, 2020.

TRD-202003568

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: October 11, 2020

For further information, please call: (512) 776-7729