TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 91. CANCER

SUBCHAPTER A. CANCER REGISTRY

25 TAC §§91.2, 91.4, 91.6, 91.7, 91.9, 91.11, 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 §§91.2, 91.4, 91.6, 91.7, 91.9, 91.11 and 91.12, concerning the operation of the Texas Cancer Registry. The amendments to §91.2 and §91.4 are adopted with changes to the proposed text as published in the November 18, 2016, issue of the Texas Register (41 TexReg 9081). The amendments to §§91.6, 91.7, 91.9, 91.11, and 91.12 are adopted without changes, and therefore the sections will not be republished.

BACKGROUND AND PURPOSE

The amendments are necessary to comply with Health and Safety Code, Chapter 82, Cancer Registry, which requires the department to maintain the Texas Cancer Registry, including who, what, where, when, and how to report cancer data to the cancer registry, as well as compliance, confidentiality, quality assurance, and requests for data.

The amendments implement House Bill (HB) 2641, 84th Legislature, Regular Session, 2015, which amended Health and Safety Code, §82.008, to authorize the submission of data through a health information exchange, and provide updated language of adopted rules to enhance the understanding of the program rules for the Texas Cancer Registry. The amendments will provide the additional option for health care providers to report data through a health information exchange.

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 required to comply with statutory requirements and to effectively operate the program.

SECTION-BY-SECTION SUMMARY

The amendments to §91.2 include deleting the definition of "branch" and replacing references to the "branch" with "Texas Cancer Registry" or "Department of State Health Services;" this change was preemptive as the Health and Human Services Transformation may affect future organizational structure. Additionally, the definition of "personal cancer data" was deleted and replaced with a new definition of "confidential cancer data" to better clarify distinctions in the types of data. In addition, a new definition for "reporting entity" was added to provide context for amendments related to health information exchange as a result of the passage of HB 2641, as well as subsequent reordering and renumbering of section.

Additional revisions were made to §91.2(3) and §91.4(b)(2), replacing the references to "cancer reporters" with "reporting entities" to provide for consistent language throughout the rule text.

The amendments to §91.4 include replacing references to "branch" with "Texas Cancer Registry."

The amendments to §91.6 include adding language to subsection (a) to allow for the submission of data to the Texas Cancer Registry through a health information exchange.

The amendments to §91.7 include replacing the reference to "branch" with "Texas Cancer Registry."

The amendments to §91.9 include inserting "cancer" in subsection (c) to clarify the requests for confidential or statistical cancer data.

The amendments to §91.11 include replacing references to "branch" with "Texas Cancer Registry," removing the phrase "and printed," and adding an email address contact in subsection (a) as another method of requesting information or cancer data. In subsection (b)(3), the word "sent" was replaced with "submitted" to be consistent with rule text.

The amendments to §91.12 include adding an email address contact, replacing a reference to "Institutional Review Board" with the "Texas Cancer Registry" in the mailing address in subsection (a)(1). The references to "branch" are being replaced with "Texas Cancer Registry." The name of §91.12 is revised to "Requests and Release of Confidential Cancer Data" and throughout the rule, "confidential cancer data" is replacing the references to "personal cancer data."

COMMENTS

The department, on behalf of the commission, has reviewed and prepared a response to the comment received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The department received a comment from Lynda Woolbert, MS, RN, CPNP-PC, FAANP, the CEO of the Coalition for Nurses in Advanced Practice (CNAP). The commenter was not against the rules in their entirety; however, the commenter suggested a recommendation for change as follows.

COMMENT: The Coalition for Nurses in Advanced Practice (CNAP) submitted a comment suggesting the inclusion of advanced practice registered nurses (APRNs) in §91.4(b)(1)(H) to allow clinical laboratories to more accurately report the name and address of the referring provider, as APRNs perform procedures and submit specimens to clinical pathology laboratories.

RESPONSE: The commission disagrees because the rule language is sufficient and consistent with the Texas Cancer Incidence Reporting Act, Health and Safety Code, Chapter 82. The rule in question, §91.4(b)(1)(H), lists what reportable information could be included in clinical laboratory information, and is not a comprehensive list. Section 91.4(b)(1)(H) refers to what information may be included in the report and does not specify the reporting entity or person. Additionally, the current statute is aimed at the accountability of health care facilities, clinical laboratories, and health care practitioners (Health and Safety Code, §82.008), as defined in the statute (Health and Safety Code, §82.002). The rule as currently written would not prohibit an APRN from including his or her information where appropriate for clinical laboratory reporting. No change to the rule was made as a result of this comment.

Section 91.2 and §91.4 are adopted with changes to the proposed text as published in the November 18, 2016, issue of the Texas Register. The department is revising §91.2(3) and §91.4(b)(2) by replacing the references to "cancer reporter" with "reporting entity" to provide consistent language throughout the rules.

LEGAL CERTIFICATION

The Department of State Health Services, General Counsel, Lisa Hernandez, 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 will be adopted under Health and Safety Code, §82.008, which provides the department with the authority to accept submissions of data through a health information exchange; 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 this subchapter, 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) 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.

(3) Cancer Reporting Handbook--The Texas Cancer Registry's manual for reporting entities that documents reporting procedures and format.

(4) Clinical laboratory--An accredited facility in which tests are performed identifying findings of anatomical changes; specimens are interpreted and pathological diagnoses are made.

(5) Confidential cancer data--Information that includes items that may identify an individual, and is subject to Health and Safety Code, §82.009.

(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) Quality assurance--Operational procedures by which the accuracy, completeness, and timeliness of the information reported to the department can be determined and verified.

(10) 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.

(11) Reporting Entity--A reporting entity may include a health care facility, clinical laboratory, health care practitioner, or a health information exchange as defined by Health and Safety Code, §182.151.

(12) Research--A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

(13) Statistical cancer 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 Department of State Health Services.

§91.4.What to Report.

(a) Reportable conditions.

(1) The cases of cancer to be reported to the Texas Cancer Registry are as follows:

(A) all neoplasms with a behavior code of two or three in the most current edition of the International Classification on Diseases for Oncology (ICD-O) of the World Health Organization with the exception of those designated by the Texas Cancer Registry as non-reportable in the Cancer Reporting Handbook; and

(B) all benign and borderline intracranial and central nervous system neoplasms as required by the national program of cancer registries.

(2) Codes and taxa of the most current edition of the International Classification of Diseases, Clinical Modification of the World Health Organization which correspond to the Texas Cancer Registry's reportable list are specified in the Cancer Reporting Handbook.

(b) Reportable information.

(1) Except as provided in paragraph (2) of this subsection and health care practitioners in §91.5(c) of this title (relating to When to Report), those data required to be reported for each cancer case shall include:

(A) name, address, zip code, and county of residence;

(B) social security number, date of birth, gender, race and ethnicity, marital status, birthplace, and primary payer at time of diagnosis, to the extent such information is available from the medical record;

(C) information on industrial and occupational history, smoking status, height and weight to the extent such information is available from the medical record;

(D) diagnostic information including the cancer site and laterality, cell type, tumor behavior, markers, grade and size, stage of disease, date of diagnosis, diagnostic confirmation method, sequence number, and other primary tumors;

(E) first course of cancer-related treatment, including dates and types of procedures;

(F) text information to support cancer diagnosis, stage and treatment codes;

(G) health care facility or practitioner related information including reporting institution number, casefinding source, type of reporting source, medical record number, registry number, tumor record number, class of case, date of first contact, date of last contact, vital status, facility referred from, facility referred to, managing physician, follow-up physician, date abstracted, abstractor, and electronic record version; and

(H) clinical laboratory related information including laboratory name and address, pathology case number, pathology report date, pathologist, and referring physician name and address.

(2) The department or its authorized representative may exempt a reporting entity from providing specific reportable data items delineated in paragraph (1) of this subsection to the extent that those data to be exempted are not collected by the reporting entity.

(3) Except as provided in §91.6(b) of this title (relating to How to Report), each report shall:

(A) be electronically readable and contain all data items required in paragraph (1) of this subsection;

(B) be fully coded and in a format prescribed by the Texas Cancer Registry;

(C) meet all quality assurance standards utilized by the Texas Cancer Registry;

(D) in the case of individuals who have more than one form of cancer, be submitted separately for each primary cancer diagnosed;

(E) be submitted to the Texas Cancer Registry electronically; and

(F) be transmitted by secure means at all times to protect the confidentiality of the data.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 13, 2017.

TRD-201701044

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: April 2, 2017

Proposal publication date: November 18, 2016

For further information, please call: (512) 776-6972


CHAPTER 97. COMMUNICABLE DISEASES

SUBCHAPTER A. CONTROL OF COMMUNICABLE DISEASES

25 TAC §§97.3, 97.4, 97.13

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §§97.3, 97.4 and 97.13, concerning the control of communicable diseases. Amendments to §97.3 and §97.4 are adopted with changes to the proposed text as published in the November 18, 2016, issue of the Texas Register (41 TexReg 9085). Section 97.13 is adopted without changes, and therefore, the section will not be republished.

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 (CDC) regarding surveillance for reportable conditions, and allow the department to conduct more relevant and efficient disease surveillance. The amendments comply with Health and Safety Code, Chapter 81, which requires the department to identify each communicable disease or health condition which is reportable under the chapter.

House Bill (HB) 2641, 84th Legislature, Regular Session, 2015, amended Health and Safety Code, §81.044, authorizing the submission of data through a health information exchange (HIE). The amendments will provide the additional option for health care providers to report data through a health information exchange.

SECTION-BY-SECTION SUMMARY

The amendments to §97.3(a)(2)(A), §97.4(a)(1), and §97.13(c), delete "causing severe acute respiratory disease" in "novel coronavirus causing severe acute respiratory disease" to make sure that all novel coronavirus infections get reported and fully investigated, not just the severe cases. In addition, §97.3(a)(2)(A) adds language to clarify what hepatitis B is reportable.

The amendments to §97.3(a)(3)(B), (C), and (D), update the names of the revised Tuberculosis forms and specify the minimal information that should be reported.

Language is added in §97.3(a)(3)(K) to encourage the reporting of "test type" by healthcare providers. In addition, the words "or practitioners" are added to be more inclusive of reporting entities.

The amendments to §97.3(a)(4), add "diphtheria (Corynebacteria diphtheria from any site)," "salmonellosis, including typhoid fever (Salmonella species)," and "all Streptococcus pneumoniae, invasive, in children under five years old (Streptococcus pneumoniae from normally sterile sites)," to the list of "Diseases requiring submission of cultures."

The amendments to §97.4(a)(1) and §97.4(a)(2) update the language to clarify when and how to report a condition or isolate. In addition, §97.4(a)(2) updates the reporting period for "mumps" from weekly to one day reporting.

The amendments to §97.4(a)(5) add language to cover possible electronic reporting including reporting by HIEs in response to amendments to HB 2641. Amendments allow electronic submission with restrictions for security, process requirements, and exceptions for conditions that must be reported immediately by phone and within one day.

COMMENTS

The department, on behalf of the commission, reviewed and prepared responses to the comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The department received written comments from the Coalition for Nurses in Advanced Practice (CNAP); Texas Medical Association Committee on Infectious Diseases; San Antonio Metropolitan Health District; Austin Public Health; and Harris County Public Health. The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments.

COMMENT: A staff member from CNAP recommended the addition of the terms "or practitioner" to §97.3(a)(3)(K) to be more inclusive of reporting entities who submit specimens to clinical laboratories.

RESPONSE: The commission agrees and §97.3(a)(3)(K) was amended to add "or practitioner" to be included in the reporting entities.

The department received comments in opposition to making influenza-associated adult deaths reportable as follows.

COMMENT: A commenter from the Texas Medical Association Committee on Infectious Diseases stated that they do not currently support the proposal to extend statewide reporting of "influenza mortality" to include deaths in adults.

Some of the concerns with the proposal included:

-the number of adult deaths from influenza is greater than the number of pediatric deaths from influenza;

-mortality from influenza and laboratory confirmation of influenza in adults is more complicated than it is in young children;

-many local public health officials may not have the resources to carry out this reporting requirement; and

-variability in local capacity for detecting and reporting influenza-associated adult deaths would affect the accuracy of data gathered across Texas.

Additionally, the commenter suggested that there are some existing surveillance tools that could be strengthened such as reporting influenza outbreaks in long-term care facilities.

COMMENT: A commenter from the San Antonio Metropolitan Health District stated that they are strongly recommending against mandatory reporting of "adult influenza-associated deaths."

Some of the concerns with the proposal included:

-the workload for San Antonio Metropolitan Health District and hospital staff would increase and the mandate would be unfunded;

-questions on how will the rule change improve early detection or control of influenza;

-the CDC already possesses well-established statistical methods for estimating influenza-associate adult mortality; and

-the rule changes were not initiated by the CDC or the Council of State and Territorial Epidemiologists.

COMMENT: A commenter from Austin Public Health stated that adding "influenza-associated death" to the reportable disease list will create an unnecessary burden for local health departments. The commenter also stated that this change would have fiscal implications.

COMMENT: A commenter from Harris County Public Health stated that quantifying "influenza-related deaths" is overall a good thing, but the concerns included:

-additional adult flu-associated death investigations and data collection required to be able to report such statistics may increase the workload of local health departments, hospital infection prevention teams and physicians;

-that their current flu surveillance system does a sufficient job describing flu activity and the number of pediatric deaths is a good proxy for flu severity in any given year; and

-that there are other less burdensome means of achieving quantifiable flu-related death information.

In order to implement the suggested changes, the commenter stated that they would need additional resources and staff to implement this mandate. As an alternative, the commenter suggested that the department provides resources to encourage collaboration among local health departments, local vital statistics units and hospitals to establish a system of electronic data retrieval for influenza associated mortalities, hospital/Intensive Care Units admissions, and other relevant variables.

RESPONSE: The commission agrees with the commenters and has decided to keep "influenza-associated pediatric mortality" as a notifiable disease condition in the State of Texas and not to move forward with the proposed change of "influenza-associated mortality" as a notifiable disease condition.

In §97.3(a)(2)(A), "influenza-associated mortality" was amended to "influenza-associated pediatric mortality" as a notifiable condition in the state.

In §97.4(a)(2), "influenza-associated pediatric mortality" was added back in the list of conditions that are reportable within one working day.

LEGAL CERTIFICATION

The Department of State Health Services, General Counsel, Lisa Hernandez, 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, §81.004, which authorizes rules necessary for the effective administration of the Communicable Disease Prevention and Control Act; §81.042, which requires a rule on the exclusion of children from schools; 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.

§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; 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; syphilis; Taenia solium and undifferentiated Taenia infections, including cysticercosis; tetanus; 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 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 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;

(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); 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 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; 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); 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 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 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.

§97.13.Death of a Person with Certain Communicable Diseases.

(a) If a physician has knowledge that a person had, at the time of death, a communicable disease listed in subsection (c) of this section, then the hospital administrator, clinic administrator, nurse, or the physician shall affix or cause to be affixed a tag on the body, preferably the great toe.

(b) The tag shall be on card stock paper and shall be no smaller than five centimeters by ten centimeters. The tag shall include the words "COMMUNICABLE DISEASE--BLOOD/BODY SUBSTANCE PRECAUTIONS REQUIRED" in letters no smaller than six millimeters in height. The name of the deceased person shall be written on the tag. The tag shall remain affixed to the body until the preparation of the body for burial has been completed.

(c) Diseases that shall require tagging are acquired immune deficiency syndrome (AIDS); anthrax; brucellosis; cholera; Hantavirus pulmonary syndrome; hepatitis, viral; human immunodeficiency virus (HIV) infection; novel coronavirus; novel influenza; plague; prion diseases, such as Creutzfeldt-Jakob disease (CJD); Q fever; rabies; Rocky Mountain spotted fever; smallpox; syphilis; tuberculosis (Mycobacterium tuberculosis complex); tularemia; and viral hemorrhagic fever.

(d) All persons should routinely practice standard infection control procedures when performing postmortem care on a deceased person who is known or suspected of having a communicable disease listed in subsection (c) of this section.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 13, 2017.

TRD-201701035

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: April 2, 2017

Proposal publication date: November 18, 2016

For further information, please call: (512) 776-6972


CHAPTER 100. IMMUNIZATION REGISTRY

25 TAC §100.1, §100.11

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), adopts an amendment to §100.1 and new §100.11, concerning the requirement to allow health information exchanges (HIEs) access to the immunization registry. Section 100.1 and §100.11 are adopted without changes to the proposed text as published in the November 18, 2016, issue of the Texas Register (41 TexReg 9088) and therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The amendment and new section are necessary to comply with House Bill (HB) 2641, 84th Legislature, Regular Session, 2015, which amended Health and Safety Code, Chapter 161, Subchapter B, Immunizations, and directed the department to allow the immunization registry to exchange data elements with an HIE as defined in Health and Safety Code, §182.151.

SECTION-BY-SECTION SUMMARY

The adopted amendment to §100.1 adds the definition of an HIE as defined in Health and Safety Code, §182.151.

The adopted new §100.11 will allow the immunization registry to exchange data elements with an HIE as defined in Health and Safety Code, §182.151. The adopted new rule will clarify procedures and requirements for the exchange of data between the immunization registry and HIEs. The new rule will stipulate that data access and transmittal will be subject to provisions of the department's data usage agreement and will state that access and transmittal of immunization registry data by an HIE must be made for immunization registry purposes only.

COMMENTS

The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, 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 amendment and new rule are adopted under Health and Safety Code, Chapter 161, which provides the department with the authority to allow Health Information Exchanges access to the immunization registry; 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.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 13, 2017.

TRD-201701036

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: April 2, 2017

Proposal publication date: November 18, 2016

For further information, please call: (512) 776-6972


CHAPTER 103. INJURY PREVENTION AND CONTROL

25 TAC §§103.1 - 103.8

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §§103.1 - 103.8, concerning injury prevention and control without changes to the proposed text as published in the November 11, 2016, issue of the Texas Register (41 TexReg 8903) and therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to Government Code, Chapter 2001 (Administrative Procedure Act). Sections 103.1 - 103.8 have been reviewed in their entirety and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed.

The department administers the state program for Injury Epidemiology and Surveillance. The Emergency Medical Services (EMS) & Trauma Registries system is operated by the Injury Epidemiology and Surveillance Branch (the Program) that collects data on reportable injuries and EMS runs submitted by the reporting health care providers (physicians, medical examiners, justices of the peace, hospitals, and acute and post-acute care rehabilitation facilities) and EMS providers.

The rules implement Health and Safety Code, Chapter 92 for the prevention and control of injuries in Texas by establishing and maintaining a trauma reporting and analysis system, investigating injuries, and providing injury related information for prevention. Senate Bill (SB) 219, 84th Texas Legislature, Regular Session, 2015, amended Health and Safety Code, Chapter 92 and replaced the "Texas Board of Health" that was abolished with the "Executive Commissioner" and the "department."

The Program develops reporting requirements, maintains registries operations, conducts data analysis, prepares reports, and provides information for injury prevention and control in Texas. The amendments to the rules clarify the rules for reporting entities. The rule revisions are expected to increase reporting, improve data quality (timeliness, accuracy, and completeness), improve compliance with reporting requirements, and ensure secure access to data by authorized system users.

SECTION-BY-SECTION SUMMARY

Changes made throughout the sections include various grammatical, punctuations, and formatting changes. Also, any reference to the "Texas EMS/Trauma Registry" has been changed to the "Texas EMS & Trauma Registries" or "Registries" in §§103.1 - 103.8. In addition to these changes, more specific changes included in the sections are described as follows.

Section 103.1(a) is being revised to replace the "Texas Board of Health" which was abolished with the "Executive Commissioner." In subsection (b), the references to "Commissioner" were replaced with "Executive Commissioner."

Section 103.2 defines the key words and terms used in the rule. The definitions of "business associate" and "paper reporting" were deleted because they are no longer relevant terms. The definitions for "data dictionaries" and "no reportable data" were added because these terms were not previously defined and are included in the rules. The definitions of "run," "spinal cord injury," "submersion injury," "traumatic brain injury," and "traumatic injury" were removed and included in the new definition of "reportable event."

Section 103.4 specifies reporting entities and lists reportable injuries and events. The list of reportable injuries and events was clarified for hospitals. The phrase "if reporting for a physician" was added to the reporting entities for a hospital and for an acute or post-acute rehabilitation facility.

Section 103.5 specifies reporting requirements for EMS providers. The section was revised to clarify the requirements for reporting "no reportable data" (NRD) and the use of third-party services to submit data to the department on behalf of the reporting entity.

Section 103.6 specifies the reporting requirements for physicians, medical examiners, and justices of the peace. This section was revised to clarify reporting requirements, such as the submittal of data electronically within ninety calendar days of the date of examination. The section also specifies that hospitals may fulfill reporting requirements on behalf of a physician as stated in §103.7. Language was also added concerning the use of third-party services to submit data to the department on behalf of the reporting entity.

Section 103.7 specifies the reporting requirements for hospitals if reporting on behalf of physicians. The section was revised to clarify the requirements for reporting, including electronic reporting within ninety calendar days, submission of NRD on a monthly basis as appropriate, and use of third-party services to submit data.

Section 103.8 specifies the reporting requirements for acute or post-acute rehabilitation facilities if reporting on behalf of physicians. The section was revised to clarify the requirements for reporting including electronic reporting within ninety calendar days, submission of NRD on a monthly basis as appropriate, and use of third-party services to submit data.

COMMENTS

The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period.

LEGAL CERTIFICATION

The Department of State Health Services, General Counsel, Lisa Hernandez, 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, §92.003, which requires the department to establish guidelines by rule for conducting injury surveillance by developing the reporting requirements of reportable injuries and events in Texas; Health and Safety Code, §773.112, which authorizes the department to adopt rules establishing requirements for data collection, including trauma incidence reporting; 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 sections implements Government Code, §2001.039.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 13, 2017.

TRD-201701039

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: April 2, 2017

Proposal publication date: November 11, 2016

For further information, please call: (512) 776-6972


CHAPTER 412. LOCAL MENTAL HEALTH AUTHORITY RESPONSIBILITIES

SUBCHAPTER I. MENTAL HEALTH CASE MANAGEMENT

25 TAC §412.403

The Executive Commissioner of the Health and Human Services Commission, on behalf of the Department of State Health Services (department), adopts an amendment to §412.403, concerning mental health case management services. An amendment to §412.403 is adopted without changes to the proposed text as published in the November 18, 2016 issue of the Texas Register (41 TexReg 9089), and therefore, the section will not be republished.

BACKGROUND AND PURPOSE

The subchapter describes requirements for providing mental health case management services funded by or through the department. The purpose of amending this section is to update the following provisions to expand the definition of "provider" to include a Local Behavioral Health Authority (LBHA) and subcontractors of an LBHA. This will allow LBHAs to subcontract for general revenue-funded case management services, and allow for continuity of care between Managed Care Organizations (MCOs) and LBHA provider networks. Fee for Service Medicaid recipients will continue to receive case management services at community mental health centers in accordance with the Medicaid State Plan.

SECTION-BY-SECTION SUMMARY

The amendment to §412.403 revises and adds definitions that are used in the subchapter.

Section 412.403(25) is being added to include a definition for an LBHA that states "An entity designated as the local behavioral health authority in accordance with Texas Health and Safety Code, §533.0356."

Section 412.403(30) is being amended to provide clarification to expand the definition of provider to include an LBHA and the LBHA's subcontractors.

COMMENTS

The department, on behalf of the commission, did not receive any comments regarding the proposed rules during the comment period.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the rule, as adopted, has been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The amendment is authorized by Health and Safety Code, §534.058, which requires the department to develop standards of care for the services provided by local mental health authorities and their subcontractors; 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.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 7, 2017.

TRD-201700865

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: March 27, 2017

Proposal publication date: November 18, 2016

For further information, please call: (512) 776-6972