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TEXAS STATUTES AND CODES

CHAPTER 161. PUBLIC HEALTH PROVISIONS

HEALTH AND SAFETY CODE

TITLE 2. HEALTH

SUBTITLE H. PUBLIC HEALTH PROVISIONS

CHAPTER 161. PUBLIC HEALTH PROVISIONS

SUBCHAPTER A. IMMUNIZATIONS

Sec. 161.0001. DEFINITIONS. In this subchapter:

(1) "Data elements" means the information:

(A) a health care provider who administers a vaccine is required

to record in a medical record under 42 U.S.C. Section 300aa-25,

as amended, including:

(i) the date the vaccine is administered;

(ii) the vaccine manufacturer and lot number of the vaccine;

(iii) any adverse or unexpected events for a vaccine; and

(iv) the name, the address, and if appropriate, the title of the

health care provider administering the vaccine; and

(B) specified in rules adopted to implement Section 161.00705.

(1-a) "First responder" means:

(A) any federal, state, local, or private personnel who may

respond to a disaster, including:

(i) public health and public safety personnel;

(ii) commissioned law enforcement personnel;

(iii) fire protection personnel, including volunteer

firefighters;

(iv) emergency medical services personnel, including hospital

emergency facility staff;

(v) a member of the National Guard;

(vi) a member of the Texas State Guard; or

(vii) any other worker who responds to a disaster in the

worker's scope of employment; or

(B) any related personnel that provide support services during

the prevention, response, and recovery phases of a disaster.

(1-b) "Immediate family member" means the parent, spouse, child,

or sibling of a person who resides in the same household as the

person.

(1-c) "Individual's legally authorized representative" means:

(A) a parent, managing conservator, or guardian of an

individual, if the individual is a minor;

(B) a guardian of the individual, if the individual has been

adjudicated incompetent to manage the individual's personal

affairs; or

(C) an agent of the individual authorized under a durable power

of attorney for health care.

(2) "Payor" means an insurance company, a health maintenance

organization, or another organization that pays a health care

provider to provide health care benefits, including providing

immunizations.

(3) "Electronically," as related to a communication authorized

under this chapter, means by e-mail, text message, online

communication, or another electronic method of communication

approved by the department.

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 1, eff. Sept. 1,

2003.

Amended by:

Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.01, eff. September 1, 2007.

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 1, eff. September 1, 2009.

Acts 2009, 81st Leg., R.S., Ch.

803, Sec. 1, eff. June 19, 2009.

Acts 2009, 81st Leg., R.S., Ch.

1280, Sec. 4.03, eff. September 1, 2009.

Sec. 161.001. LIABILITY OF PERSON WHO ORDERS OR ADMINISTERS

IMMUNIZATION. (a) A person who administers or authorizes the

administration of a vaccine or immunizing agent is not liable for

an injury caused by the vaccine or immunizing agent if the

immunization is required by the board or is otherwise required by

law or rule.

(b) A person who administers or authorizes the administration of

a vaccine or immunizing agent is not liable or responsible for

the failure to immunize a child because of the failure or refusal

of a parent, managing conservator, or guardian to consent to the

vaccination or immunization required under this chapter. Consent

to the vaccination or immunization must be given in the manner

authorized by Chapter 32, Family Code.

(c) A person who fails to comply with Section 161.004 is not

liable or responsible for that failure, and that failure does not

create a cause of action.

(d) This section does not apply to a negligent act in

administering the vaccine or immunizing agent.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Amended by Acts 1993, 73rd Leg., ch. 43, Sec. 2, eff. Sept. 1,

1993; Acts 1997, 75th Leg., ch. 165, Sec. 7.40, eff. Sept. 1,

1997.

Sec. 161.002. INADMISSIBILITY OF IMMUNIZATION SURVEY

INFORMATION. Information obtained from a physician's medical

records by a person conducting an immunization survey for the

department is not admissible as evidence in a suit against the

physician that involves an injury relating to the immunization of

an individual.

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 161.003. IMMUNIZATION REMINDER NOTICES. (a) In a program

administered by the department in which an immunization reminder

notice is sent regarding the immunization of a child, the notice

must be sent without discrimination based on the legitimacy of

the child.

(b) The reminder notice must be addressed to an adult or parent

and may not use:

(1) an indication of the marital status of the addressee; or

(2) the terms "Mr.," "Mrs.," "Miss," or "Ms."

Acts 1989, 71st Leg., ch. 678, Sec. 1, eff. Sept. 1, 1989.

Sec. 161.004. STATEWIDE IMMUNIZATION OF CHILDREN. (a) Every

child in the state shall be immunized against vaccine preventable

diseases caused by infectious agents in accordance with the

immunization schedule adopted by the board.

(b) Hospitals shall be responsible for:

(1) referring newborns for immunization at the time the newborn

screening test is performed;

(2) reviewing the immunization history of every child admitted

to the hospital or examined in the hospital's emergency room or

outpatient clinic; and

(3) administering needed vaccinations or referring the child for

immunization.

(c) Physicians shall be responsible for reviewing the

immunization history of every child examined and administering

any needed vaccinations or referring the child for immunization.

(d) A child is exempt from an immunization required by this

section if:

(1) a parent, managing conservator, or guardian states that the

immunization is being declined for reasons of conscience,

including a religious belief; or

(2) the immunization is medically contraindicated based on the

opinion of a physician licensed by any state in the United States

who has examined the child.

(e) For purposes of this section, "child" means a person under

18 years of age.

(f) The board shall adopt rules that are necessary to administer

this section.

(g) A parent, managing conservator, or guardian may choose the

health care provider who administers the vaccine or immunizing

agent under this chapter.

Added by Acts 1993, 73rd Leg., ch. 43, Sec. 3, eff. Sept. 1,

1993. Amended by Acts 2003, 78th Leg., ch. 198, Sec. 2.162, eff.

Sept. 1, 2003.

Sec. 161.0041. IMMUNIZATION EXEMPTION AFFIDAVIT FORM. (a) A

person claiming an exemption from a required immunization based

on reasons of conscience, including a religious belief, under

Section 161.004 of this code, Section 38.001 or 51.933, Education

Code, or Section 42.043, Human Resources Code, must complete an

affidavit on a form provided by the department stating the reason

for the exemption.

(b) The affidavit must be signed by the person claiming the

exemption or, if the person is a minor, the person's parent,

managing conservator, or guardian, and the affidavit must be

notarized.

(c) A person claiming an exemption from a required immunization

under this section may only obtain the affidavit form by

submitting a written request for the affidavit form to the

department.

(d) The department shall develop a blank affidavit form that

contains a seal or other security device to prevent reproduction

of the form. The affidavit form shall contain a statement

indicating that the person or, if a minor, the person's parent,

managing conservator, or guardian understands the benefits and

risks of immunizations and the benefits and risks of not being

immunized.

(e) The department shall maintain a record of the total number

of affidavit forms sent out each year and shall report that

information to the legislature each year. The department may not

maintain a record of the names of individuals who request an

affidavit under this section.

Added by Acts 2003, 78th Leg., ch. 198, Sec. 2.163, eff. Sept. 1,

2003.

Sec. 161.005. IMMUNIZATIONS REQUIRED. (a) On admission of a

child to a facility of the Texas Department of Mental Health and

Mental Retardation, the Texas Department of Criminal Justice, or

the Texas Youth Commission, the facility physician shall review

the immunization history of the child and administer any needed

vaccinations or refer the child for immunization.

(b) The department and the board have the same powers and duties

under this section as those entities have under Sections 38.001

and 51.933 , Education Code. In addition, the provisions of those

sections relating to provisional admissions and exceptions apply

to this section.

(c) A facility covered by this section shall keep an individual

immunization record during the individual's period of admission,

detention, or commitment in the facility, and the records shall

be open for inspection at all reasonable times by a

representative of the local health department or the department.

(d) This section does not affect the requirements of Section

38.001 or 51.933, Education Code, or Section 42.043, Human

Resources Code.

Added by Acts 1993, 73rd Leg., ch. 43, Sec. 3, eff. Sept. 1,

1993. Amended by Acts 1997, 75th Leg., ch. 165, Sec. 6.41, eff.

Sept. 1, 1997.

Sec. 161.0051. REQUIRED IMMUNIZATIONS FOR NURSING HOMES. (a)

This section applies only to a nursing home that:

(1) is an institution licensed under Chapter 242; and

(2) serves residents who are elderly persons as defined by

Section 242.002.

(b) The board by rule may require nursing homes to offer, in

accordance with an immunization schedule adopted by the board,

immunizations to elderly residents or to staff who are in contact

with elderly residents against diseases that the board determines

to be:

(1) caused by infectious agents;

(2) potentially deadly; and

(3) preventable by vaccine.

(c) The board by rule shall require nursing homes to offer, in

accordance with an immunization schedule adopted by the board:

(1) pneumococcal vaccine to elderly residents; and

(2) influenza vaccine to elderly residents and to staff who are

in contact with elderly residents.

Added by Acts 1999, 76th Leg., ch. 259, Sec. 1, eff. Sept. 1,

1999.

Sec. 161.0052. IMMUNIZATION OF ELDERLY PERSONS BY HOSPITALS, END

STAGE RENAL DISEASE FACILITIES, AND PHYSICIANS' OFFICES. (a) In

this section:

(1) "Elderly person" means a person who is 65 years of age or

older.

(2) "End stage renal disease facility" has the meaning assigned

by Section 251.001.

(3) "Hospital" has the meaning assigned by Section 241.003.

(b) The executive commissioner of the Health and Human Services

Commission by rule shall require a hospital to inform each

elderly person admitted to the hospital for a period of 24 hours

or more that the pneumococcal and influenza vaccines are

available. If the elderly person requests a vaccine, and if a

physician, or an advanced nurse practitioner or physician

assistant on behalf of a physician, determines that the vaccine

is in the person's best interest, the hospital must make the

vaccination available to the person before the person is

discharged from the hospital.

(c) The executive commissioner of the Health and Human Services

Commission by rule shall require an end stage renal disease

facility to offer, to the extent possible as determined by the

facility, the opportunity to receive the pneumococcal and

influenza vaccines to each elderly person who receives ongoing

care at the facility if a physician, or an advanced nurse

practitioner or physician assistant on behalf of a physician,

determines that the vaccine is in the person's best interest. If

the facility decides it is not feasible to offer the vaccine, the

facility must provide the person with information on other

options for obtaining the vaccine.

(d) The Texas State Board of Medical Examiners by rule shall

require a physician responsible for the management of a

physician's office that provides ongoing medical care to elderly

persons to offer, to the extent possible as determined by the

physician, the opportunity to receive the pneumococcal and

influenza vaccines to each elderly person who receives ongoing

care at the office. If the physician decides it is not feasible

to offer the vaccine, the physician must provide the person with

information on other options for obtaining the vaccine.

(e) Rules adopted under this section must require that:

(1) a hospital, end stage renal disease facility, or physician's

office:

(A) offer the influenza vaccine in October and November, and if

the vaccine is available, December; and

(B) offer the pneumococcal vaccine year-round; and

(2) a person administering a vaccine:

(A) ask whether the elderly person is currently vaccinated

against the influenza virus or pneumococcal disease, as

appropriate;

(B) administer the vaccine under institution-approved or

physician-approved protocols after making an assessment for

contraindications; and

(C) permanently document the vaccination in the elderly person's

medical records.

(f) In adopting rules under this section, the executive

commissioner of the Health and Human Services Commission and the

Texas State Board of Medical Examiners shall consider the

recommendations of the Advisory Committee on Immunization

Practices of the Centers for Disease Control and Prevention.

(g) Rules adopted under this section may consider the potential

for a shortage of a vaccine.

(h) The department shall make available to hospitals and end

stage renal disease facilities, and the Texas State Board of

Medical Examiners shall make available to physicians' offices,

educational and informational materials concerning vaccination

against influenza virus and pneumococcal disease.

Added by Acts 2005, 79th Leg., Ch.

368, Sec. 1, eff. September 1, 2005.

Sec. 161.006. DEPARTMENT IMMUNIZATION SERVICE. The department,

to the extent permitted by law, is authorized to pay employees

who are exempt or not exempt for purposes of the Fair Labor

Standards Act of 1938 (29 U.S.C. Section 201 et seq.) on a

straight-time basis for work on a holiday or for regular

compensatory time hours when the taking of regular compensatory

time off would be disruptive to normal business operations.

Authorization for payment under this section is limited to work

directly related to immunizations.

Added by Acts 1993, 73rd Leg., ch. 43, Sec. 3, eff. Sept. 1,

1993.

Sec. 161.007. IMMUNIZATION REGISTRY; REPORTS TO DEPARTMENT. (a)

The department, for the primary purpose of establishing and

maintaining a single repository of accurate, complete, and

current immunization records to be used in aiding, coordinating,

and promoting efficient and cost-effective communicable disease

prevention and control efforts, shall establish and maintain an

immunization registry. The executive commissioner of the Health

and Human Services Commission by rule shall develop guidelines

to:

(1) protect the confidentiality of patients in accordance with

Section 159.002, Occupations Code;

(2) inform the individual or the individual's legally authorized

representative about the registry and that registry information

may be released under Section 161.00735;

(3) require the written or electronic consent of the individual

or the individual's legally authorized representative before any

information relating to the individual is included in the

registry;

(4) permit the individual or the individual's legally authorized

representative to withdraw consent for the individual to be

included in the registry; and

(5) determine the process by which consent is verified,

including affirmation by a health care provider, birth registrar,

regional health information exchange, or local immunization

registry that consent has been obtained.

(a-1) The written or electronic consent required by Subsection

(a)(3) for an individual younger than 18 years of age is required

to be obtained only one time. The consent is valid until the

individual becomes 18 years of age unless the consent is

withdrawn in writing or electronically. A parent, managing

conservator, or guardian of a minor may provide the consent by

using an electronic signature on the minor's birth certificate.

(a-2) An individual's legally authorized representative or the

individual, after the individual has attained 18 years of age,

may consent in writing or electronically for the individual's

information to remain in the registry after the individual's 18th

birthday and for the individual's subsequent immunizations to be

included in the registry. The written or electronic consent of

the minor's legally authorized representative as described by

Section 161.0001(1-c)(A) must be submitted to the department

before the individual's 18th birthday. The written or electronic

consent of the individual or the individual's legally authorized

representative as described by Section 161.0001(1-c)(B) or (C)

must be submitted to the department not later than the

individual's 19th birthday. The consent of the representative or

individual is valid until the individual or the individual's

legally authorized representative withdraws consent in writing or

electronically. The department may not include in the registry

the immunization information of an individual who is 18 years of

age or older until written or electronic consent has been

obtained as provided by this subsection. The department shall

coordinate with the Texas Education Agency to distribute

materials described in Section 161.0095(a)(2) to students and

parents through local school districts.

(a-3) The executive commissioner of the Health and Human

Services Commission by rule shall develop guidelines and

procedures for obtaining consent from an individual after the

individual's 18th birthday, including procedures for retaining

immunization information in a separate database that is

inaccessible by any person other than the department during the

one-year period during which an 18-year-old may consent to

inclusion in the registry under Subsection (a-2).

(b) Except as provided by Section 161.0071, the immunization

registry must contain information on the immunization history

that is obtained by the department under:

(1) this section of each individual for whom consent has been

obtained in accordance with guidelines adopted under Subsection

(a) or (a-3), as applicable;

(2) Section 161.00705 of persons immunized to prepare for or in

response to a declared disaster, public health emergency,

terrorist attack, hostile military or paramilitary action, or

extraordinary law enforcement emergency;

(3) Section 161.00706 of first responders or their immediate

family members; and

(4) Section 161.00735 of persons evacuated or relocated to this

state because of a disaster.

(b-1) The department shall remove from the registry information

for any individual for whom consent has been withdrawn. The

department may not retain individually identifiable information

about any individual:

(1) for whom consent has been withdrawn;

(2) for whom a consent for continued inclusion in the registry

following the end of the declared disaster, public health

emergency, terrorist attack, hostile military or paramilitary

action, or extraordinary law enforcement emergency has not been

received under Section 161.00705(f);

(3) for whom a request to be removed from the registry has been

received under Section 161.00706(e);

(4) for whom consent for continued inclusion in the registry

following the end of a disaster has not been received under

Section 161.00735(f); or

(5) for whom a request to remove information from the registry

has been received under Section 161.00735(g).

(c) A payor that receives data elements from a health care

provider who administers an immunization to an individual younger

than 18 years of age shall provide the data elements to the

department. A payor is required to provide the department with

only the data elements the payor receives from a health care

provider. A payor that receives data elements from a health care

provider who administers an immunization to an individual 18

years of age or older may provide the data elements to the

department. The data elements shall be submitted in a format

prescribed by the department. The department shall verify

consent before including the reported information in the

immunization registry. The department may not retain

individually identifiable information about an individual for

whom consent cannot be verified.

(d) A health care provider who administers an immunization to an

individual younger than 18 years of age shall provide data

elements regarding an immunization to the department. A health

care provider who administers an immunization to an individual 18

years of age or older may submit data elements regarding an

immunization to the department. The data elements shall be

submitted in a format prescribed by the department. The

department shall verify consent before including the information

in the immunization registry. The department may not retain

individually identifiable information about an individual for

whom consent cannot be verified.

(e) The department shall provide notice to a health care

provider that submits an immunization history for an individual

for whom consent cannot be verified. The notice shall contain

instructions for obtaining consent in accordance with guidelines

adopted under Subsections (a) and (a-3) and resubmitting the

immunization history to the department.

(f) The department and health care providers may use the

registry to provide notices by mail, telephone, personal contact,

or other means to an individual or the individual's legally

authorized representative regarding an individual who is due or

overdue for a particular type of immunization according to the

department's immunization schedule for children or another

analogous schedule recognized by the department for individuals

18 years of age or older. The department shall consult with

health care providers to determine the most efficient and

cost-effective manner of using the registry to provide those

notices.

(g) The department shall provide instruction and education to

providers about the immunization registry provider application

and enrollment process. The department shall:

(1) initially target providers in the geographic regions of the

state with immunization rates below the state average for

preschool children; and

(2) expedite the processing of provider applications.

(h) Nothing in this section diminishes a parent's, managing

conservator's, or guardian's responsibility for having a child

immunized properly, subject to Section 161.004(d).

(i) A person, including a health care provider, payor, or an

employee of the department who submits or obtains in good faith

immunization data elements to or from the department in

compliance with the provisions of this section and any rules

adopted under this section is not liable for any civil damages.

(j) Except as provided by Sections 161.00705, 161.00706,

161.00735(b), and 161.008, information obtained by the department

for the immunization registry is confidential and may be

disclosed only with the written or electronic consent of the

individual or the individual's legally authorized representative.

(k) The executive commissioner of the Health and Human Services

Commission shall adopt rules to implement this section.

Added by Acts 1997, 75th Leg., ch. 900, Sec. 1, eff. Sept. 1,

1997. Amended by Acts 2001, 77th Leg., ch. 1420, Sec. 14.780,

eff. Sept. 1, 2001; Acts 2003, 78th Leg., ch. 1081, Sec. 2.

Amended by:

Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.03, eff. September 1, 2007.

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 2, eff. September 1, 2009.

Acts 2009, 81st Leg., R.S., Ch.

35, Sec. 1, eff. September 1, 2009.

Sec. 161.00705. RECORDING ADMINISTRATION OF IMMUNIZATION AND

MEDICATION FOR DISASTERS AND EMERGENCIES. (a) The department

shall maintain a registry of persons who receive an immunization,

antiviral, and other medication administered to prepare for a

potential disaster, public health emergency, terrorist attack,

hostile military or paramilitary action, or extraordinary law

enforcement emergency or in response to a declared disaster,

public health emergency, terrorist attack, hostile military or

paramilitary action, or extraordinary law enforcement emergency.

A health care provider who administers an immunization,

antiviral, or other medication shall provide the data elements to

the department.

(b) The department shall maintain the registry as part of the

immunization registry required by Section 161.007.

(c) The department shall track adverse reactions to an

immunization, antiviral, and other medication administered to

prepare for a potential disaster, public health emergency,

terrorist attack, hostile military or paramilitary action, or

extraordinary law enforcement emergency or in response to a

declared disaster, public health emergency, terrorist attack,

hostile military or paramilitary action, or extraordinary law

enforcement emergency. A health care provider who administers an

immunization, antiviral, or other medication may provide data

related to adverse reactions to the department.

(d) Sections 161.007, 161.0071, 161.0072, and 161.0074 apply to

the data elements submitted to the department under this section,

unless a provision in those sections conflicts with a requirement

in this section.

(e) The executive commissioner of the Health and Human Services

Commission by rule shall determine the period during which the

information collected under this section must remain in the

immunization registry following the end of the disaster, public

health emergency, terrorist attack, hostile military or

paramilitary action, or extraordinary law enforcement emergency.

(f) Unless an individual or the individual's legally authorized

representative consents in writing or electronically to continued

inclusion of the individual's information in the registry, the

department shall remove the immunization records collected under

this section from the registry on expiration of the period

prescribed under Subsection (e).

(g) The immunization information of a child or other individual

received by the department under this section, including

individually identifiable information, may be released only:

(1) on consent of the individual or, if a child, the child's

parent, managing conservator, or guardian; or

(2) to a state agency or health care provider consistent with

the purposes of this subchapter or the purposes of aiding or

coordinating communicable disease prevention and control efforts

during a declared disaster, public health emergency, terrorist

attack, hostile military or paramilitary action, or extraordinary

law enforcement emergency.

(h) The report required under Section 161.0074 must also include

the number of complaints received by the department related to

the department's failure to remove information from the registry

as required by Subsection (f).

(i) The executive commissioner of the Health and Human Services

Commission shall adopt rules necessary to implement this section.

Added by Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.02, eff. September 1, 2007.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 3, eff. September 1, 2009.

Sec. 161.00706. FIRST RESPONDER IMMUNIZATION INFORMATION. (a)

A person 18 years of age or older who is a first responder or an

immediate family member of a first responder may:

(1) request that a health care provider who administers an

immunization to the person provide data elements regarding the

immunization to the department for inclusion in the immunization

registry; or

(2) provide the person's immunization history directly to the

department for inclusion in the immunization registry.

(b) A health care provider, on receipt of a request under

Subsection (a)(1), shall submit the data elements to the

department in a format prescribed by the department. The

department shall verify the person's request before including the

information in the immunization registry.

(c) The executive commissioner of the Health and Human Services

Commission shall:

(1) develop rules to ensure that immunization history submitted

under Subsection (a)(2) is medically verified immunization

information;

(2) develop guidelines for use by the department in informing

first responders about the registry and that registry information

may be released under Section 161.00735; and

(3) adopt rules necessary for the implementation of this

section.

(d) Except as provided by Section 161.00735, a person's

immunization history or data received by the department under

this section may be released only on consent of the person or to

any health care provider licensed or otherwise authorized to

administer vaccines.

(e) A person whose immunization records are included in the

immunization registry as authorized by this section may request

in writing or electronically that the department remove that

information from the registry. Not later than the 10th day after

receiving a request under this subsection, the department shall

remove the person's immunization records from the registry.

(f) The report required under Section 161.0074 must also include

the number of complaints received by the department related to

the department's failure to comply with requests for removal of

information from the registry under Subsection (e).

Added by Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.02, eff. September 1, 2007.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 4, eff. September 1, 2009.

Acts 2009, 81st Leg., R.S., Ch.

35, Sec. 2, eff. September 1, 2009.

Sec. 161.00707. INFORMATION AND EDUCATION FOR FIRST RESPONDERS.

The department shall develop a program for informing first

responders about the immunization registry and educating first

responders about the benefits of being included in the

immunization registry, including:

(1) ensuring that first responders receive necessary

immunizations to prevent the spread of communicable diseases to

which a first responder may be exposed during a public health

emergency, declared disaster, terrorist attack, hostile military

or paramilitary action, or extraordinary law enforcement

emergency; and

(2) preventing duplication of vaccinations.

Added by Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.02, eff. September 1, 2007.

Sec. 161.0071. NOTICE OF RECEIPT OF REGISTRY DATA; EXCLUSION

FROM REGISTRY. (a) The first time the department receives

registry data for an individual for whom the department has

received consent to be included in the registry, the department

shall send notice to the individual or the individual's legally

authorized representative disclosing:

(1) that providers and payors may be sending the individual's

immunization information to the department;

(2) the information that is included in the registry;

(3) the persons to whom the information may be released under

Sections 161.00735(b) and 161.008(d);

(4) the purpose and use of the registry;

(5) the procedure to exclude an individual from the registry;

and

(6) the procedure to report a violation if an individual's

information is included in the registry after exclusion has been

requested or consent has been withdrawn.

(b) On discovering that consent to be included in the registry

has not been granted or has been withdrawn, the department shall

exclude the individual's immunization records from the registry

and any other registry-related department record that

individually identifies the individual.

(c) On receipt of a written or electronic request to exclude an

individual's immunization records from the registry, the

department shall send to the individual or the individual's

legally authorized representative who makes the request a written

confirmation of receipt of the request for exclusion and shall

exclude the individual's records from the registry.

(d) The department commits a violation if the department fails

to exclude an individual's immunization information from the

registry as required by Subsection (b) or (c).

(e) The department shall accept a written or electronic

statement from an individual or the individual's legally

authorized representative communicating to the department that an

individual's information should be excluded from the registry,

including a statement on a minor's birth certificate, as a

request for exclusion under Subsection (c).

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 3, eff. Sept. 1,

2003.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 5, eff. September 1, 2009.

Acts 2009, 81st Leg., R.S., Ch.

35, Sec. 3, eff. September 1, 2009.

Sec. 161.0072. PROVIDING IMMUNIZATION INFORMATION TO DEPARTMENT.

(a) If the individual or the individual's legally authorized

representative has reasonable concern that the individual's

health care provider is not submitting the immunization history

to the department, the individual or the individual's legally

authorized representative may provide the individual's

immunization history directly to the department to be included in

the immunization registry.

(b) The individual or the individual's legally authorized

representative may send evidence of the individual's immunization

history to the department electronically, by facsimile

transmission, or by mail. The evidence may include a copy of:

(1) the individual's medical record indicating the immunization

history;

(2) an invoice from a health care provider for the immunization;

or

(3) documentation showing that a claim for the immunization was

paid by a payor.

(c) The board shall develop rules to ensure that the

immunization history submitted by an individual or the

individual's legally authorized representative is medically

verified immunization information.

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 3, eff. Sept. 1,

2003.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 6, eff. September 1, 2009.

Sec. 161.0073. REGISTRY CONFIDENTIALITY. (a) Except as

provided by Sections 161.00705 and 161.00735, information that

individually identifies an individual that is received by the

department for the immunization registry is confidential and may

be used by the department for registry purposes only.

(b) Unless specifically authorized under this subchapter, the

department may not release registry information to any individual

or entity without the consent of the individual or the

individual's legally authorized representative.

(c) A person required to report information to the department

for registry purposes or authorized to receive information from

the registry may not disclose the individually identifiable

information of an individual to any other person without the

written or electronic consent of the individual or the

individual's legally authorized representative, except as

provided by Chapter 159, Occupations Code, or Section 602.053,

Insurance Code.

(d) Registry information is not:

(1) subject to discovery, subpoena, or other means of legal

compulsion for release to any person or entity except as provided

by this subchapter; or

(2) admissible in any civil, administrative, or criminal

proceeding.

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 3, eff. Sept. 1,

2003.

Amended by:

Acts 2005, 79th Leg., Ch.

728, Sec. 11.127, eff. September 1, 2005.

Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.04, eff. September 1, 2007.

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 7, eff. September 1, 2009.

Acts 2009, 81st Leg., R.S., Ch.

35, Sec. 4, eff. September 1, 2009.

Sec. 161.00735. RELEASE AND RECEIPT OF REGISTRY DATA IN

DISASTER. (a) In this section, "disaster" means a disaster

declared by the president of the United States, the governor of

this state, or the governor of another state.

(b) If the department determines that residents of this state

have evacuated or relocated to another state in response to a

disaster, the department may release registry data, except

registry data obtained under Section 161.00705, to the

appropriate health authority of that state or to local health

authorities in that state.

(c) The department may receive immunization information from a

health authority of another state or from a local health

authority in another state if the department determines that

residents of that state have evacuated or relocated to this state

in response to a disaster. The department shall include

information received under this subsection in the registry.

Notwithstanding Section 161.007, the department is not required

to obtain written consent for the inclusion in the registry of

information received under this subsection.

(d) Immunization information received under Subsection (c) is

subject to Section 161.0073, and may not be released except as

authorized by this chapter.

(e) The executive commissioner of the Health and Human Services

Commission, by rule, shall determine the period during which the

information collected under Subsection (c) must remain in the

immunization registry following the end of the disaster.

(f) Unless an individual or, if a child, the child's parent,

managing conservator, or guardian consents in writing to

continued inclusion of the individual's or child's information in

the registry, the department shall remove the immunization

records collected under Subsection (c) from the registry on the

expiration of the period prescribed by Subsection (e).

(g) If an individual or, if a child, the child's parent,

managing conservator, or guardian requests in writing that the

individual's or child's information obtained under Subsection (c)

be removed from the registry, the department shall remove that

information from the registry.

(h) The executive commissioner of the Health and Human Services

Commission shall make every effort to enter into a memorandum of

agreement with each state to which residents of this state are

likely to evacuate in a disaster on:

(1) the release and use of registry information under this

section to the appropriate health authority or local health

authority of that state, including the length of time the

information may be retained by that state; and

(2) the receipt and use of information submitted by the health

authority or local health authority of that state for inclusion

in the registry under this section.

Added by Acts 2009, 81st Leg., R.S., Ch.

35, Sec. 5, eff. September 1, 2009.

Sec. 161.0074. REPORT TO LEGISLATURE. (a) The department shall

report to the Legislative Budget Board, the governor, the

lieutenant governor, the speaker of the house of representatives,

and appropriate committees of the legislature not later than

September 30 of each even-numbered year.

(b) The department shall use the report required under

Subsection (a) to develop ways to increase immunization rates

using state and federal resources.

(c) The report must:

(1) include the current immunization rates by geographic region

of the state, where available;

(2) focus on the geographic regions of the state with

immunization rates below the state average for preschool

children;

(3) describe the approaches identified to increase immunization

rates in underserved areas and the estimated cost for each;

(4) identify changes to department procedures needed to increase

immunization rates;

(5) identify the services provided under and provisions of

contracts entered into by the department to increase immunization

rates in underserved areas;

(6) identify performance measures used in contracts described by

Subdivision (5);

(7) include the number and type of exemptions used in the past

year;

(8) include the number of complaints received by the department

related to the department's failure to comply with requests for

exclusion of individuals from the registry;

(9) identify all reported incidents of discrimination for

requesting exclusion from the registry or for using an exemption

for a required immunization;

(10) include department recommendations about the best way to

use, and communicate with, local registries in the state; and

(11) include ways to increase provider participation in the

registry.

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 3, eff. Sept. 1,

2003.

Sec. 161.0075. IMMUNITY FROM LIABILITY. Except as provided by

Section 161.009, the following persons subject to this subchapter

that act in compliance with Sections 161.007, 161.00705,

161.00706, 161.0071, 161.0073, 161.0074, and 161.008 are not

civilly or criminally liable for furnishing the information

required under this subchapter:

(1) a payor;

(2) a health care provider who administers immunizations; and

(3) an employee of the department.

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 3, eff. Sept. 1,

2003.

Amended by:

Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.05, eff. September 1, 2007.

Sec. 161.0076. COMPLIANCE WITH FEDERAL LAW. If the provisions

of this chapter relating to the use or disclosure of information

in the registry are more stringent than the Health Insurance

Portability and Accountability Act and Privacy Standards, as

defined by Section 181.001, then the use or disclosure of

information in the registry is governed by this chapter.

Added by Acts 2003, 78th Leg., ch. 1081, Sec. 3, eff. Sept. 1,

2003.

Sec. 161.008. IMMUNIZATION RECORD. (a) An immunization record

is part of the immunization registry.

(b) An immunization record contains the:

(1) name and date of birth of the person immunized;

(2) dates of immunization;

(3) types of immunization administered; and

(4) name and address of the health care provider administering

the immunization.

(c) The department may obtain the data constituting an

immunization record for an individual from a public health

district, a local health department, the individual or the

individual's legally authorized representative, a physician to

the individual, a payor, or any health care provider licensed or

otherwise authorized to administer vaccines. The department

shall verify consent before including the reported information in

the immunization registry. The department may not retain

individually identifiable information about an individual for

whom consent cannot be verified.

(d) The department may release the data constituting an

immunization record for the individual to:

(1) any entity that is described by Subsection (c);

(2) a school or child care facility in which the individual is

enrolled; or

(3) a state agency having legal custody of the individual.

(e) An individual or the individual's legally authorized

representative may obtain and on request to the department shall

be provided with all individually identifiable immunization

registry information concerning the individual.

(f) A person, including a health care provider, a payor, or an

employee of the department, that submits in good faith an

immunization history or data to or obtains in good faith an

immunization history or data from the department in compliance

with the provisions of this section and any rules adopted under

this section is not liable for any civil damages.

(g) The department may release nonidentifying summary statistics

related to the registry that do not individually identify an

individual.

(h) The executive commissioner of the Health and Human Services

Commission shall adopt rules to implement this section.

Added by Acts 1997, 75th Leg., ch. 900, Sec. 1, eff. Sept. 1,

1997. Amended by Acts 2003, 78th Leg., ch. 1081, Sec. 4, eff.

Sept. 1, 2003.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 8, eff. September 1, 2009.

Sec. 161.009. PENALTIES FOR DISCLOSURE OF INFORMATION. (a) A

person commits an offense if the person:

(1) negligently releases or discloses immunization registry

information in violation of Section 161.007, 161.0071, 161.0073,

or 161.008;

(2) fails to exclude an individual's immunization information in

violation of Section 161.0071;

(3) fails to remove a person's immunization information in

violation of Section 161.00705, 161.00706, or 161.00735; or

(4) negligently uses information in the immunization registry to

solicit new patients or clients or for other purposes that are

not associated with immunization or quality-of-care purposes,

unless authorized under this section.

(b) An offense under this section is a Class A misdemeanor.

Added by Acts 1997, 75th Leg., ch. 900, Sec. 1, eff. Sept. 1,

1997. Amended by Acts 2003, 78th Leg., ch. 1081, Sec. 5.

Amended by:

Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.06, eff. September 1, 2007.

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 9, eff. September 1, 2009.

Acts 2009, 81st Leg., R.S., Ch.

35, Sec. 6, eff. September 1, 2009.

Sec. 161.0095. EDUCATION PROGRAMS AND INFORMATION. (a) The

department shall develop:

(1) continuing education programs for health care providers

relating to immunizations and the vaccines for children program

operated by the department under authority of 42 U.S.C. Section

1396s; and

(2) educational information, for health care providers, health

care clinics, hospitals, and any other health care facility that

provides health care to children 14 to 18 years of age, relating

to the immunization registry and the option for an individual who

is 18 years of age or older to consent to submission and

retention of the individual's information in the immunization

registry.

(b) The department shall establish a work group to assist the

department in developing the continuing education programs and

educational information. The work group shall include

physicians, nurses, department representatives, representatives

of managed care organizations that provide health care services

under Chapter 533, Government Code, representatives of health

plan providers that provide health care services under Chapter

62, and members of the public.

Added by Acts 2003, 78th Leg., ch. 613, Sec. 1, eff. Sept. 1,

2003.

Amended by:

Acts 2009, 81st Leg., R.S., Ch.

9, Sec. 10, eff. September 1, 2009.

Sec. 161.010. IMMUNIZATION EDUCATION; STATEWIDE COALITION. (a)

The department shall establish a continuous statewide education

program to educate the public about the importance of immunizing

children and the risks and contraindications of an immunization.

(b) The department shall increase coordination among public and

private local, regional, and statewide entities that have an

interest in immunizations.

Added by Acts 2003, 78th Leg., ch. 125, Sec. 1, eff. Sept. 1,

2003.

Sec. 161.0101. INCREASE IMMUNIZATION AWARENESS. (a) The

department shall develop new public-private partnerships and work

with existing public-private partnership programs, including the

Seniors and Volunteers Program For Childhood Immunization, to

increase public and private awareness of and support for early

childhood immunizations.

(b) The department shall work with the Texas Education Agency to

increase immunization awareness and participation among parents

of preschool and school-age children by:

(1) jointly applying for federal funds for immunization

awareness and vaccination programs; and

(2) creating partnerships with public and private health,

service, and education organizations, including parent-teacher

associations, the United Way, schools, local businesses,

community-based organizations, chambers of commerce, and athletic

booster clubs, to increase awareness and participation in the

state's early childhood vaccination program.

(c) The department shall work to increase immunization awareness

and participation among parents of children in child-care

facilities, as defined by Section 42.002, Human Resources Code,

in the state's early childhood vaccination program by publishing

on the department's website information about the benefits of

annual immunization against influenza for children aged six

months to five years. The department shall work with the

Department of Family and Protective Services and with child-care

facilities to ensure that the information is annually distributed

to parents in August or September.

Added by Acts 2003, 78th Leg., ch. 844, Sec. 1, eff. Sept. 1,

2003.

Renumbered from Health and Safety Code, Section 161.010 by Acts

2005, 79th Leg., Ch.

728, Sec. 23.001(44), eff. September 1, 2005.

Amended by:

Acts 2007, 80th Leg., R.S., Ch.

922, Sec. 1, eff. June 15, 2007.

Sec. 161.0102. VACCINES FOR CHILDREN PROGRAM; INFLUENZA

VACCINES. (a) In this section, "vaccines for children program"

means the program operated by the department under authority of

42 U.S.C. Section 1396s, as amended.

(b) The department shall allow each health care provider

participating in the vaccines for children program to:

(1) select influenza vaccines from the list of all influenza

vaccines that:

(A) are approved by the United States Food and Drug

Administration and recommended by the federal Advisory Committee

on Immunization Practices; and

(B) are either:

(i) within the limits of the vaccines annually allocated by the

Centers for Disease Control and Prevention of the United States

Public Health Service to the department for the vaccines for

children program; or

(ii) not offered in the annual allocation under Subparagraph

(i), but are available from the Centers for Disease Control and

Prevention of the United States Public Health Service and for

which the Centers for Disease Control and Prevention awards to

the department additional funds; and

(2) use both inactivated influenza vaccines and live, attenuated

influenza vaccines.

Added by Acts 2007, 80th Leg., R.S., Ch.

397, Sec. 1, eff. June 15, 2007.

Text of section effective until September 01, 2010

Sec. 161.0103. VACCINES FOR CHILDREN PROGRAM; EQUIVALENT

VACCINES. (a) In this section:

(1) "Vaccines for children program" means the program operated

by the department under authority of 42 U.S.C. Section 1396s.

(2) "Equivalent vaccines" means two or more vaccines, excluding

the influenza vaccine, that protect a recipient of a vaccine

against the same infection or infections, that require the same

number of doses, and that have similar safety and efficacy

profiles and which are recommended for comparable populations.

(b) Except as provided by Subsection (d), where two or more

manufacturers produce equivalent vaccines, the department shall

procure an equal supply of the vaccine from each manufacturer.

(c) An equivalent vaccine must be:

(1) approved by the United States Food and Drug Administration;

(2) recommended by the federal Advisory Committee on

Immunization Practices; and

(3) made available to the department by the Centers for Disease

Control and Prevention of the United States Public Health

Service.

(d) The department shall procure an equal supply of each

equivalent vaccine under Subsection (b) only if the cost to the

department of providing each equivalent vaccine is not more than

110 percent of the lowest-priced equivalent vaccine.

Added by Acts 2007, 80th Leg., R.S., Ch.

397, Sec. 2, eff. June 15, 2007.

Sec. 161.01035. PROVIDER CHOICE SYSTEM. (a) The department

shall implement a provider choice system for the vaccines for

children program operated by the department under authority of 42

U.S.C. Section 1396s and the adult safety net vaccination

program.

(b) The department shall ensure that eligible health care

providers participating in the vaccines for children program or

the adult safety net vaccination program may select any licensed

vaccine, including combination vaccines and any dosage forms

that:

(1) are recommended by the federal Advisory Committee on

Immunization Practices;

(2) are made available to the department by the Centers for

Disease Control and Prevention of the United States Public Health

Service; and

(3) for adult vaccines, are on the department-approved list of

vaccines offered by the adult safety net vaccination program.

(c) For the purposes of this section, "equivalent vaccines"

means two or more vaccines, excluding the influenza vaccine, that

meet all of the following:

(1) protect a recipient of a vaccine against the same infection

or infections;

(2) require the same number of doses;

(3) have similar safety and efficacy profiles; and

(4) are recommended for comparable populations by the Centers

for Disease Control and Prevention of the United States Public

Health Service.

(d) The department shall provide a vaccine selected by a health

care provider under Subsection (b) only if the cost to the

department of providing the vaccine is not more than 115 percent

of the lowest-priced equivalent vaccine.

(e) This section does not apply in the event of a disaster or

public health emergency, terrorist attack, hostile military or

paramilitary action, or extraordinary law enforcement emergency.

(f) The department shall convene the immunization work group

established under Section 161.0095 and solicit its

recommendations regarding development of a plan for the

implementation of the provider choice system under this section.

The plan shall include the education of participating health care

providers about:

(1) procedures and distribution systems of the Centers for

Disease Control and Prevention of the United States Public Health

Service; and

(2) vaccine options, the enrollment process, ordering,

accountability, and reporting procedures.

Added by Acts 2009, 81st Leg., R.S., Ch.

258, Sec. 1, eff. September 1, 2009.

Sec. 161.0104. DISASTER PREPARATION. The department shall

consult with public health departments and appropriate health

care providers to identify adult immunizations that may be

necessary to respond to or prepare for a disaster or public

health emergency, terrorist attack, hostile military or

paramilitary action, or extraordinary law enforcement emergency.

Added by Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.07, eff. September 1, 2007.

Renumbered from Health and Safety Code, Section 161.0102 by Acts

2009, 81st Leg., R.S., Ch.

87, Sec. 27.001(52), eff. September 1, 2009.

Sec. 161.0105. LIMITATION ON LIABILITY. (a) A health care

provider who acts in compliance with Sections 161.007, 161.00705,

161.00706, and 161.008 and any rules adopted under those sections

is not civilly or criminally liable for furnishing the

information required under those sections. This subsection does

not apply to criminal liability established under Section

161.009.

(b) A person who administers a vaccination under a department

program may be held liable only to the extent the person would be

liable if the person administered the vaccination outside the

program. The person is not liable for damages arising from the

acts or omissions of another person acting under the program or

the department.

(c) The immunity created by this section is in addition to any

immunity created by Sections 161.001 and 161.007(g).

Added by Acts 2003, 78th Leg., ch. 844, Sec. 1, eff. Sept. 1,

2003.

Amended by:

Acts 2007, 80th Leg., R.S., Ch.

258, Sec. 12.08, eff. September 1, 2007.

Sec. 161.0106. RESPIRATORY SYNCYTIAL VIRUS; IMMUNIZATION. As

part of the education programs under Sections 161.0095 and

161.010, the department shall include information about:

(1) respiratory syncytial virus and the importance of

preventative activities for children at risk of contracting the

virus;

(2) respiratory syncytial virus prophylaxis for children who are

at high risk of complications from the disease; and

(3) immunization for respiratory syncytial virus when a vaccine

is recommended and available.

Added by Acts 2005, 79th Leg., Ch.

115, Sec. 1, eff. September 1, 2005.

Sec. 161.0107. ELECTRONIC MEDICAL RECORDS SYSTEMS. (a) In this

section:

(1) "Electronic medical records software package or system"

means an electronic system for maintaining medical records in the

clinical setting.

(2) "Medical records" has the meaning assigned by Section

151.002, Occupations Code.

(b) A person who sells, leases, or otherwise provides an

electronic medical records software package or system to a person

who administers immunizations in this state or to an entity that

manages records for the person shall provide, as part of the

electronic medical records software package or system, the

ability to:

(1) electronically interface with the immunization registry

created under this subchapter; and

(2) generate electronic reports that contain the fields

necessary to populate the immunization registry.

(c) The executive commissioner of the Health and Human Services

Commission by rule shall specify:

(1) the fields necessary to populate the immunization registry,

including a field that indicates the patient's consent to be

listed in the immunization registry has been obtained; and

(2) the data standards that must be used for electronic

submission of immunization information.

(d) The data standards specified under Subsection (b) must be

compatible with the standards for immunization information

transmission adopted by the Healthcare Information Technology

Standards Panel sponsored by the American National Standards

Institute and included in certification criteria by the

Certification Commission for Healthcare Information Technology.

Added by Acts 2007, 80th Leg., R.S., Ch.

352, Sec. 1, eff. June 15, 2007.

Sec. 161.0108. INJUNCTION. (a) The attorney general may bring

an action in the name of the state to enjoin a violation of

Section 161.0107.

(b) If the state prevails in a suit under this section, the

attorney general may recover on behalf of the state reasonable

attorney's fees, court costs, and reasonable investigative costs

incurred in relation to the proceeding.

Added by Acts 2007, 80th Leg., R.S., Ch.

352, Sec. 1, eff. June 15, 2007.

Sec. 161.0109. HUMAN PAPILLOMAVIRUS; VACCINES EDUCATION

MATERIALS. (a) The department, using existing resources, shall

produce and distribute informational materials regarding vaccines

against human papillomavirus that are approved by the United

States Food and Drug Administration for human use. The materials

must include information relating to the effectiveness,

availability, and contraindications of the vaccines. The

materials must be available in English and in Spanish.

(b) The department shall collaborate with the Texas Cancer

Council or its successor entity to develop educational programs

for parents regarding human papillomavirus and promoting

awareness of a minor's need for preventive services for cervical

cancer and its precursors.

(c) The department shall develop and maintain an Internet

website that targets the public and health care professionals and

provides accurate, comprehensive information on all aspects of

cervical cancer prevention, including vaccination against human

papillomavirus.

Added by Acts 2007, 80th Leg., R.S., Ch.

59, Sec. 1, eff. September 1, 2007.

Renumbered from Health and Safety Code, Section 161.0107 by Acts

2009, 81st Leg., R.S., Ch.

87, Sec. 27.001(53), eff. September 1, 2009.

SUBCHAPTER B. HEALTH INSPECTION OF PRIVATE RESIDENCE

Sec. 161.011. PERMISSION REQUIRED. A person, including an

officer or agent of this state or of an

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