TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 40. EPINEPHRINE AUTO-INJECTOR AND ANAPHYLAXIS POLICIES

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §§40.11 - 40.18, concerning Epinephrine Auto-Injector Policies in Certain Entities, and new §§40.21 - 40.28, concerning Epinephrine Auto-Injector Policies in Youth Facilities.

BACKGROUND AND PURPOSE

The purpose of the proposal is to implement House Bill (H.B.) 1849 and H.B. 4260, 86th Legislature, Regular Session, 2019, which amended Texas Human Resources Code, Chapter 42, Subchapter C, and Texas Health and Safety Code, Chapter 773, Subchapter A. The bills require the adoption of rules for the stocking and administering of unassigned epinephrine auto-injectors in amusement parks, restaurants, sports venues, child-care facilities, day camps or youth camps, youth centers, small employer-based day-care facilities, temporary shelter day-care facilities, and listed family homes that voluntarily adopt unassigned epinephrine auto-injector policies. If a venue or youth facility voluntarily adopts a policy, trained personnel or volunteers may administer an epinephrine auto-injector to a person reasonably believed to be experiencing anaphylaxis.

DSHS convened the Stock Epinephrine Advisory Committee (SEAC) to request recommendations on how to integrate evidence-based practices in the rules while allowing flexibility for the entities and youth facilities. The SEAC recommended stocking at least one adult epinephrine auto-injector pack, the required training to implement the rules, and the requirement to report the administration of an epinephrine auto-injector to DSHS within 10 business days after the administration of an epinephrine auto-injector. The proposed new rules allow flexibility so that venues and youth facilities may develop policies specific to each location, including geography and venue population size.

SECTION-BY-SECTION SUMMARY

Proposed new §40.11 describes the purpose of the subchapter, which is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors in entities that voluntarily adopt epinephrine auto-injector policies.

Proposed new §40.12 states that specified entities may adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each venue's property. If a written policy is voluntarily adopted under this subchapter, the policy must comply with Texas Health and Safety Code, §773.0145, and this subchapter.

Proposed new §40.13 defines terms used in the rules relating to the maintenance, administration, and disposal of epinephrine auto-injectors in certain entities.

Proposed new §40.14 states that the rules apply to any venue that chooses to voluntarily adopt and implement a written policy regarding the maintenance, administration, and disposal of epinephrine auto-injectors at each venue.

Proposed new §40.15 addresses unassigned epinephrine auto-injector policy requirements in venues.

Proposed new §40.16 addresses training requirements for venue personnel and venue volunteers in the administration of epinephrine auto-injectors and recognition of anaphylaxis.

Proposed new §40.17 addresses the required reporting of administering an epinephrine auto-injector.

Proposed new §40.18 addresses the immunity from liability as outlined in this subchapter and Texas Health and Safety Code, §773.0145.

Proposed new §40.21 addresses the purpose of the subchapter, which is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors in youth facilities that voluntarily adopt epinephrine auto-injector policies.

Proposed new §40.22 states that a youth facility may voluntarily adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each youth facility.

Proposed new §40.23 defines terms used in the rules relating to the maintenance, administration, and disposal of epinephrine auto-injectors in youth facilities.

Proposed new §40.24 states that the rules apply to any youth facility that voluntarily chooses to adopt and implement a written policy regarding the maintenance, administration, and disposal of epinephrine auto-injectors.

Proposed new §40.25 addresses unassigned epinephrine auto-injector policy requirements in youth facilities.

Proposed new §40.26 addresses training of facility personnel in the administration of epinephrine auto-injectors and the recognition of anaphylaxis.

Proposed new §40.27 addresses the required reporting of administering an epinephrine auto-injector.

Proposed new §40.28 addresses immunity from liability as outlined in this subchapter and Texas Health and Safety Code, §773.0145.

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

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

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

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

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

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

(5) the proposed rules will create new rules;

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

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

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

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

Donna Sheppard, Chief Financial Officer, has also determined that there will be an adverse economic effect on small businesses, micro-businesses, or rural communities.

There are approximately 18,635 youth camps, child-care facilities, small employer- based day-care facilities, temporary shelter day-care facilities, and listed family homes that may be classified as small businesses or micro-businesses. DSHS is unable to determine the number of small businesses or micro-businesses for youth centers, amusement parks, restaurants, and sports venues. The only cost is the cost to voluntarily comply with the proposed rules.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Dr. Manda Hall, Associate Commissioner, has determined that for each year of the first five years the rules are in effect, the public will benefit from the adoption of the rules. The public will benefit because amusement parks, restaurants, sports venues, child-care facilities, day camps or youth camps, youth centers, small employer-based day-care facilities, temporary shelter day-care facilities, and listed family homes that voluntarily adopt unassigned epinephrine auto-injector policies will be able to administer epinephrine auto-injectors to individuals suspected of experiencing anaphylaxis. By administering epinephrine auto-injectors to people suspected of anaphylaxis, many lives may be saved.

Donna Sheppard, Chief Financial Officer, has also determined that for the first five years the rules are in effect, persons who voluntarily comply with the proposed rules may incur economic costs. It is estimated that 1 pack of epinephrine auto-injectors will cost between $300 and $600. There are approximately 360 youth camps, 15,192 child-care facilities, 10 small employer-based day-care facilities, 12 temporary shelter day-care facilities, and 3,061 listed family homes. DSHS is unable to determine the number of youth centers, amusement parks, restaurants, and sports venues in Texas. Based on the available data, the cost will be between $5,590,500 and $11,181,000. This will depend on how many of the entities choose to voluntarily adopt a policy.

DSHS is assuming that the cost for the hands-on training with an epinephrine auto-injector trainer will cost $20 per person. Assuming youth camps, child-care facilities, small employer-based day-care facilities, temporary shelter day-care facilities, and listed family homes trains at least 1 person to administer the epinephrine auto-injector, the total cost to train 1 person per venue or youth facility will be $372,700 each year. Therefore, depending on the cost of the epinephrine auto-injector pack, the minimum total cost of compliance is between $5,963,200 and $11,553,700 per year ($320-$620 per venue or youth facility per year). Because participation is voluntary, the overall cost could be less. This estimate does not include the cost to replace an epinephrine auto-injector that is used, nor does it include the costs if a venue or youth facility chooses to purchase more than one pack.

TAKINGS IMPACT ASSESSMENT

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

PUBLIC COMMENT

Questions about the content of this proposal may be directed to Anita Wheeler at (512) 776-2909 in DSHS, Community Health Improvement Division, School Health Program.

Written comments on the proposal may be submitted to Anita Wheeler, School Nurse Consultant, School Health Program, P.O. Box 149347, Austin, Texas 78714-9347, via fax at (512) 776-7555, or by email to SchoolHealth@dshs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or e-mailing comments, please indicate "Comments on Proposed Rule 20R018" in the subject line.

SUBCHAPTER B. EPINEPHRINE AUTO-INJECTOR POLICIES IN CERTAIN ENTITIES

25 TAC §§40.11 - 40.18

STATUTORY AUTHORITY

The new sections are authorized by Texas Health and Safety Code, §773.0145, which authorizes the Executive Commissioner of HHSC to adopt rules regarding the stocking and administering of unassigned epinephrine auto-injectors in amusement parks, restaurants, sports venues, child-care facilities, day camps or youth camps, youth centers, small employer-based day-care facilities, temporary shelter day-care facilities, and listed family homes that voluntarily adopt unassigned epinephrine auto-injector policies. The new sections are also authorized by Texas Government Code, §531.0055 and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules and policies necessary for the operation and provision of services by DSHS, and for the administration of Texas Health and Safety Code, Chapter 1001.

The new sections implement Texas Health and Safety Code, Chapter 773 and Chapter 1001 and Texas Government Code, §531.0055.

§40.11.Purpose.

The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors for a specified entity that adopts an unassigned epinephrine auto-injector policy. These standards are implemented under Texas Health and Safety Code, Chapter 773, Subchapter A.

§40.12.Voluntary Unassigned Epinephrine Auto-injector Policies for Certain Entities.

Specified entities may adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each venue's property. The adopted policy must comply with the standards outlined in Texas Health and Safety Code §773.0145 and this subchapter.

§40.13.Definitions.

The following terms and phrases, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:

(1) Anaphylaxis--As defined in Texas Education Code §51.881.

(2) Authorized healthcare provider--A physician or person who has been delegated prescriptive authority by a physician under Texas Occupations Code Chapter 157, as described in Texas Health and Safety Code §773.0145.

(3) Personnel--Employees and volunteers of a venue.

(4) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the venue issued with a non-patient-specific standing order for the administration of an epinephrine auto-injector.

(5) Venue--An entity offering a place of public gathering including:

(A) an amusement park, as defined by Texas Penal Code §46.035;

(B) a restaurant, as defined by Texas Business and Commerce Code §17.821; or

(C) a sports venue, as defined by Texas Local Government Code §504.151.

(6) Volunteer--A person who:

(A) is providing services for or on behalf of a venue on the premises of the venue, or providing services for or on behalf of a venue at an offsite sponsored event or related activity; and

(B) does not receive compensation in excess of reimbursement for expenses.

§40.14.Applicability.

This subchapter applies to any venue that voluntarily adopts and implements a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each venue.

§40.15.Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors.

(a) A venue shall obtain a prescription and standing order from an authorized healthcare provider each year to stock, possess, and maintain at least one unassigned adult epinephrine auto-injector pack (two doses) on each venue's property, as described in Texas Health and Safety Code §773.0145. The number of additional adult packs may be determined by an individual venue assessment led by an authorized health-care provider, based on available resources.

(b) A venue performing such an assessment may consider:

(1) consultation with office of risk management, office of food services, or any department involved with public well-being;

(2) venue geography, including high risk areas; and

(3) venue occupancy limit.

(c) In developing an epinephrine auto-injector policy, a venue shall designate:

(1) a department to coordinate and manage policy implementation, which shall include:

(A) conducting an assessment;

(B) training venue personnel;

(C) purchasing (or otherwise acquiring), storing, and using unassigned epinephrine auto-injectors; and

(D) disposing of used or expired unassigned epinephrine auto-injectors;

(2) personnel who can be trained to administer unassigned epinephrine auto-injectors;

(3) locations for unassigned epinephrine auto-injectors;

(4) procedures for notifying local emergency medical services when a member of the venue or volunteer suspects a person is experiencing anaphylaxis and when an epinephrine auto-injector is administered; and

(5) a plan to replace, as soon as reasonably possible, any unassigned epinephrine auto-injector that is used, and to replace any unused unassigned epinephrine auto-injector upon or prior to its expiration.

(d) The policy and the locations of the unassigned epinephrine auto-injector must be publicly available, and the unassigned epinephrine auto-injector must be stored in accordance with the manufacturer's guidelines.

§40.16.Training.

(a) Each venue that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for training venue personnel and venue volunteers in the recognizing of anaphylaxis signs and symptoms and hands-on administration of an unassigned epinephrine auto-injector.

(b) Training shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention.

(c) Each venue shall maintain training records and each venue shall make available upon request a list of those venue personnel or venue volunteers trained and authorized to administer the unassigned epinephrine auto-injector on the venue's property.

§40.17.Report on Administering Unassigned Epinephrine Auto-Injectors.

(a) The venue that adopts a policy for administering unassigned epinephrine auto-injectors shall submit a report no later than the 10th business day after the date an epinephrine auto-injection is administered, in accordance with the unassigned epinephrine auto-injector policy adopted under this subchapter. The report shall be submitted to the prescribing physician and the Department of State Health Services (DSHS).

(b) Notifications to the commissioner of DSHS shall be submitted on the designated electronic form available on the DSHS School Health Program website, available at dshs.texas.gov.

§40.18.Immunity from Liability.

A person who in good faith takes, or fails to take, any action under this subchapter or Texas Health and Safety Code, Chapter 773, Subchapter A, is immune from civil or criminal liability or disciplinary action resulting from that action or failure to act in accordance with the Texas Health and Safety Code §773.0145.

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

Filed with the Office of the Secretary of State on October 2, 2020.

TRD-202004115

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: November 15, 2020

For further information, please call: (512) 776-7279


SUBCHAPTER C. EPINEPHRINE AUTO-INJECTOR POLICIES IN YOUTH FACILITIES

25 TAC §§40.21 - 40.28

STATUTORY AUTHORITY

The new sections are authorized by Texas Health and Safety Code, §773.0145, which authorizes the Executive Commissioner of HHSC to adopt rules regarding the stocking and administering of unassigned epinephrine auto-injectors in amusement parks, restaurants, sports venues, child-care facilities, day camps or youth camps, youth centers, small employer-based day-care facilities, temporary shelter day-care facilities, and listed family homes that voluntarily adopt unassigned epinephrine auto-injector policies. The new sections are also authorized by Texas Government Code, §531.0055 and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall adopt rules and policies necessary for the operation and provision of services by DSHS, and for the administration of Texas Health and Safety Code, Chapter 1001.

The new sections implement Texas Health and Safety Code, Chapter 773 and Chapter 1001 and Texas Government Code, §531.0055.

§40.21.Purpose.

The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors for a youth facility that adopts unassigned epinephrine auto-injector policies. These standards are implemented under Texas Health and Safety Code, Chapter 773, Subchapter A.

§40.22.Voluntary Unassigned Epinephrine Auto-injector Policies for Youth Facilities.

A youth facility may voluntarily adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each youth facility. If a written policy is adopted under this subchapter, the policy must comply with Texas Health and Safety Code, §773.0145, and this subchapter.

§40.23. Definitions.

The following terms and phrases, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:

(1) Anaphylaxis--As defined in Texas Human Resources Code, §42.067.

(2) Authorized healthcare provider--A physician, or person who has been delegated prescriptive authority by a physician under Texas Occupations Code, Chapter 157 as described in Texas Health and Safety Code, §773.0145.

(3) Personnel--Employees or volunteers of a youth facility.

(4) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the youth facility, issued with a non-patient-specific standing order for the administration of an epinephrine auto-injector.

(5) Youth facility is:

(A) a child-care facility, as defined by Texas Human Resources Code, §42.002;

(B) a day camp or youth camp, as defined by Texas Health and Safety Code, §141.002;

(C) a youth center, as defined by Texas Health and Safety Code, §481.134;

(D) a small employer-based day-care facility, as defined by Texas Human Resources Code, §42.151;

(E) a temporary shelter day-care facility, as defined by Texas Human Resources Code, §42.201;

(F) a listed family home, as defined by Texas Human Resources Code, §42.052(c); or

(G) any other private or public entity that would benefit from the possession and administration of epinephrine auto-injectors, that provide services for youth under the age of eighteen.

§40.24.Applicability.

This subchapter applies to any youth facility that voluntarily chooses to adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors.

§40.25.Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors.

(a) A youth facility (facility) shall stock at least one unassigned pediatric epinephrine auto-injector pack (two doses) and one adult epinephrine auto-injector pack (two doses). The number of additional pediatric and adult packs may be determined by a facility assessment led by an authorized health-care provider, based on available resources, in accordance with this subchapter.

(b) A facility with greater than 100 youth and staff that voluntarily adopts an unassigned epinephrine auto-injector policy shall conduct an assessment to determine the minimum number of additional unassigned epinephrine auto-injectors and may consider as a part of an assessment:

(1) consultation with administrators, office of risk management, food services management, or any department involved with public well-being;

(2) facility geography, including high risk areas where food exposure or environmental trigger exposure may occur;

(3) enrollment limit and number of personnel; and

(4) the number of youth with an identified allergy.

(c) An unassigned epinephrine auto-injector policy shall include:

(1) a designated administrator to coordinate and manage policy implementation;

(2) an assessment, if greater than 100 youth and staff;

(3) a training policy for personnel that is consistent with §40.22 of this subchapter (relating to Training);

(4) a requirement to obtain a prescription from an authorized healthcare provider each year to stock, possess, and maintain the minimum number of unassigned epinephrine auto-injectors, described in §40.20 of this subchapter (relating to Applicability), to be dispensed by an authorized pharmacy, as defined by Texas Occupations Code, Chapter 560, §560.001;

(5) a requirement to obtain a standing order designating how and when to administer an unassigned epinephrine auto-injector;

(6) the number of unassigned epinephrine auto-injectors at the facility;

(7) a process to verify the inventory of unassigned epinephrine auto-injectors at regular intervals for expiration and replacement;

(8) a plan to replace, as soon as reasonably possible, any unassigned epinephrine auto-injector when used or close to expiration;

(9) a requirement that the unassigned epinephrine auto-injectors be stored according to manufacturer's instructions;

(10) designation of one or more secure and easily-accessible locations to store unassigned epinephrine auto-injectors; and

(11) procedures for notifying local emergency medical services when a person is suspected of experiencing anaphylaxis and when an epinephrine auto-injector is administered.

(d) If a facility implements an unassigned epinephrine auto-injector policy under this subchapter, the facility must provide written or electronic notice to a parent or guardian of each youth enrolled within 15 calendar days.

(e) If a facility changes or discontinues the policy adopted under this subchapter, the facility must provide a written or electronic notice detailing the change or discontinuation to a parent or guardian of each youth within 15 calendar days of the change or discontinuation.

§40.26.Training.

(a) Each youth facility (facility) that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for annually training personnel to recognize the signs and symptoms of anaphylaxis and to perform hands-on administration of an unassigned epinephrine auto-injector.

(b) Training shall be consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention.

(c) Each facility shall maintain and make available upon request:

(1) a list of personnel trained and authorized to administer the unassigned epinephrine auto-injector; and

(2) annual training records for such personnel.

§40.27.Report on Administering Unassigned Epinephrine Auto-Injectors.

(a) The youth facility (facility) shall submit a report no later than the 10th business day after the date facility personnel administer an unassigned epinephrine auto-injector. The report shall be submitted to the owner of the facility, the prescribing physician, and the Department of State Health Services (DSHS).

(b) Notifications to DSHS shall be submitted on the designated electronic form available on DSHS's School Health Program website found at dshs.texas.gov. DSHS will submit a copy of the report to the Child Care Regulation Department of the Texas Health and Human Services Commission.

§40.28.Immunity from Liability.

A person who in good faith takes, or fails to take, any action under this subchapter or Texas Health and Safety Code, Chapter 773, Subchapter A, is immune from civil or criminal liability or disciplinary action resulting from that action or failure to act in accordance with the Texas Health and Safety Code, §773.0145.

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

Filed with the Office of the Secretary of State on October 2, 2020.

TRD-202004116

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: November 15, 2020

For further information, please call: (512) 776-7279


SUBCHAPTER D. MAINTENANCE AND ADMINISTRATION OF ASTHMA MEDICATION

25 TAC §§40.41 - 40.49

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §§40.41 - 40.49, concerning Maintenance and Administration of Asthma Medication.

BACKGROUND AND PURPOSE

The purpose of the proposal is to implement House Bill (H.B.) 2243, 86th Legislature, Regular Session, 2019, which amended Texas Education Code, Chapter 38 Subchapter E. H.B. 2243 allows school districts, open-enrollment charter schools, and private schools to develop a policy to stock and administer asthma medication to a student if the student is reasonably believed to be experiencing a symptom of asthma; the school nurse has written authorization from a parent or guardian of the student stating that the school nurse may administer prescription asthma medication to the student; and the student has been diagnosed as having asthma.

DSHS convened the Stock Epinephrine Advisory Committee (SEAC) to request recommendations on how to integrate evidence-based practices in the rules while allowing flexibility for the school districts and schools. The SEAC recommended to stock at least two doses of medication, the type of medication, the inclusion of the equipment to have on hand to administer the medication, and to report the administration of asthma medication to the DSHS Commissioner within 10 business days after administration of the medicine. The proposed new rules allow flexibility so that schools may develop policies specific to each campus, including campus geography and student population size.

SECTION-BY-SECTION SUMMARY

Proposed new §40.41 states the purpose of the subchapter, which is to establish minimum standards for administering, maintaining, and disposing of unassigned asthma medication in school districts, open-enrollment charter schools, and private schools that voluntarily adopt unassigned asthma medication policies.

Proposed new §40.42 defines terms used in the subchapter.

Proposed new §40.43 states that the rules apply to any school district, open enrollment charter school, or private school that voluntarily chooses to adopt and implement a written unassigned asthma medication policy.

Proposed new §40.44 addresses unassigned asthma medication policy requirements in school districts, open-enrollment charter schools, and private schools.

Proposed new §40.45 addresses the prescription, administration, and disposal of unassigned asthma medication.

Proposed new §40.46(a) states that a school district, open enrollment charter school, or private school that chooses to adopt a written unassigned asthma medication policy, or a campus that is subject to this subchapter is responsible for training school nurses. Subsection (b) states that a list of trained nurses be available upon request.

Proposed new §40.47 addresses retaining records related to implementing and administering the unassigned asthma medication policy and reporting incidences of medication administration to DSHS with 10 days after the date a school nurse administers asthma medication via the DSHS's website.

Proposed new §40.48 addresses the requirements for notifying parents or guardians of the unassigned asthma medication policy.

Proposed new §40.49 addresses the immunity of liability as outlined in Texas Education Code, §38.215(a).

FISCAL NOTE

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

GOVERNMENT GROWTH IMPACT STATEMENT

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

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

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

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

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

(5) the proposed rules will create new rules;

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

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

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

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

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities, as participation in providing the new service described in the proposed rules is voluntary.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code, §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and implement legislation that does not specifically state that §2001.0045 applies to the rules.

PUBLIC BENEFIT AND COSTS

Manda Hall, MD, Associate Commissioner, Community Health Improvement Division, has determined that for each year of the first five years that the rules will be in effect, the public benefit will be that the safety of students with asthma on school campuses will be improved for schools that voluntarily adopt unassigned asthma medication policies.

Donna Sheppard has also determined that for the first five years the rules are in effect, schools that voluntarily comply with the proposed rules may incur economic costs because the cost of the asthma medication and supplies is between $150 and $400 per campus. Based on data from the Texas Education Agency for school year 2017-2018, there are approximately 8,766 public and charter school campuses in Texas. According to the Texas Private School Commission, there are approximately 1,326 accredited private schools in Texas. If the price of the medication is $150, then the total cost for all public, private, and open-enrollment charter schools per fiscal year is $1,513,800. If the price is $400, then the total cost to schools per fiscal year is $4,036,800. Because participation is voluntary, the overall cost could be less. This estimate does not include the cost to replace the asthma medication or the equipment to administer the medication nor does it include the costs if a school chooses to purchase additional doses of medication or more equipment. Schools may utilize free asthma medication programs, if available.

TAKINGS IMPACT ASSESSMENT

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

PUBLIC COMMENT

Questions about the content of this proposal may be directed to Anita Wheeler at (512) 776-7279 in DSHS, Community Health Improvement Division, School Health Program.

Written comments on the proposal may be submitted to School Health Program, P.O. Box 149347, Austin, Texas 78714-9347, or 1100 West 49th Street, Austin, Texas 78756, faxed to (512) 776-7555, or emailed to Schoolhealth@dshs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rule 20R019" in the subject line.

STATUTORY AUTHORITY

The new sections are required to comply with Texas Education Code, Chapter 38, Subchapter E. The new sections are also authorized by Texas Government Code §531.0055, and Texas Health and Safety Code, §1001.075, which authorizes the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001.

The new sections implement Texas Education Code, Chapter 38, Texas Government Code, §531.0055, and Texas Health and Safety Code, Chapter 1001.

§40.41.Purpose.

The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of unassigned asthma medication for school districts, open-enrollment charter schools, and private schools that voluntarily adopt unassigned asthma medication policies. These standards are implemented under Texas Education Code Chapter 38 Subchapter E.

§40.42.Definitions.

The following terms and phrases, when used in this subchapter, have the following meanings, unless the context clearly indicates otherwise:

(1) Authorized healthcare provider--A physician, as defined in Texas Education Code, §38.201, or person who has been delegated prescriptive authority by a physician under Texas Occupations Code Chapter 157.

(2) Campus--A geographic unit of a school district, open-enrollment charter school, or private school that:

(A) has an assigned administrator;

(B) has enrolled students who are counted for average daily attendance;

(C) has assigned instructional staff;

(D) provides instructional services to students;

(E) has one or more grades in the range from early childhood education through grade 12 or is ungraded; and

(F) is subject to Texas laws.

(3) School nurse--Registered nurse, as defined in 19 TAC §153.1022 (relating to Minimum Salary Schedule for Certain Professional Staff), authorized to administer asthma medication, or licensed vocational nurse working under supervision as described in Texas Occupations Code §301.353.

(4) Unassigned asthma medication--A fast acting bronchodilator delivered by metered dose inhaler with single use spacer or by nebulizer as a rescue medication, prescribed by an authorized healthcare provider in the name of the school district, open-enrollment charter school, or private school, issued with a non-patient-specific standing delegation order for the administration of an asthma medication, and issued by an authorized healthcare provider.

§40.43.Applicability.

This subchapter applies to any school district, open-enrollment charter school, or private school that voluntarily adopts and implements a written policy regarding the maintenance, administration, and disposal of unassigned asthma medication on each campus.

§40.44.Voluntary Unassigned Asthma Medication Policies.

(a) A school district, open-enrollment charter school, or private school may voluntarily adopt and implement a written policy regarding the maintenance, administration, and disposal of asthma medication at each campus.

(1) If a written policy is adopted under this subchapter, the unassigned asthma medication policy must comply with Texas Education Code §38.208.

(2) Subject to the availability of funding, a school district, open-enrollment charter school, private school, or campus that adopts such a policy must purchase or obtain the suggested minimum dosage of unassigned asthma medication.

(b) In development of an unassigned asthma medication policy, a campus may consider performing an assessment to include:

(1) consultation with school nurses, the local school health advisory committee, local healthcare providers, or any department or organization involved with student well-being;

(2) campus geography; and

(3) student population size.

(c) If a school district, open-enrollment charter school, or private school voluntarily adopts an unassigned asthma medication policy, the policy must include:

(1) a process to obtain written authorization from a parent or guardian of the student that the student has been diagnosed as having asthma and stating that the school nurse may administer unassigned asthma medication to the student;

(2) a designated campus department to coordinate and manage policy implementation that includes:

(A) conducting an assessment;

(B) training of school nurses;

(C) acquiring or purchasing, maintaining, storing, and using unassigned asthma medication, subject to available campus funding; and

(D) disposing of expired unassigned asthma medication;

(3) a list of school nurses who will be assigned to administer unassigned asthma medication;

(4) locations of unassigned asthma medication;

(5) procedures for notifying a parent, prescribing physician, and the student's primary healthcare provider when unassigned asthma medication is administered; and

(6) a plan to replace, as soon as reasonably possible, any unassigned asthma medication that is used or close to expiration.

(d) An adopted unassigned asthma medication policy must be publicly available.

§40.45.Prescription, Administration, and Disposal of Unassigned Asthma Medications.

(a) A campus that adopts an unassigned asthma medication policy must stock unassigned asthma medication, subject to available funding, as defined by §40.44 of this subchapter (relating to Voluntary Unassigned Asthma Medication Policies).

(b) A campus must obtain a prescription from an authorized healthcare provider each year to stock, possess, and maintain at least two doses of unassigned asthma medication on each campus as described in Texas Education Code §38.208 and any equipment necessary to administer the medication.

(1) The campus must renew this prescription or obtain a new prescription annually.

(2) The number of additional doses may be determined by an individual campus assessment led by an authorized healthcare provider, based on available funding.

(c) An authorized healthcare provider who prescribes unassigned asthma medication under subsection (b) of this section must provide the campus with a standing order for the administration of unassigned asthma medication to a person who:

(1) is reasonably believed to be experiencing a symptom of asthma; and

(2) has provided written notification and permission as required by the unassigned asthma medication policy.

(d) The unassigned asthma medication must be stored in accordance with the manufacturer's guidelines and local district policy.

(e) Expired unassigned asthma medication and other used or expired supplies must be disposed of in accordance with the manufacturer's guidelines and local district policy.

§40.46.Training.

(a) A school district, open-enrollment charter school, or private school that chooses to adopt a written unassigned asthma medication policy, or a campus that is subject to this subchapter, is responsible for training school nurses about:

(1) the adopted unassigned asthma medication policy;

(2) the authorized or prescribing healthcare provider's standing order;

(3) follow-up with the prescribing healthcare provider and the student's primary care physician; and

(4) the report required after administering an unassigned asthma medication under §40.47 of this subchapter (relating to Report on Administering Unassigned Asthma Medication).

(b) Each campus must maintain training records and must make available upon request a list of school nurses trained and authorized to administer the unassigned asthma medication on the campus.

§40.47.Report on Administering Unassigned Asthma Medication.

(a) Records relating to implementing and administering the school district, open-enrollment charter school, or private school's unassigned asthma medication policy must be retained per the campus record retention schedule.

(b) The campus must submit a report no later than the 10th business day after the date a school nurse administers asthma medication in accordance with the unassigned asthma medication policy adopted under this subchapter. The report must be included in the student's permanent record and submitted to the school administrator, prescribing healthcare provider, the student's primary healthcare provider, and to the Department of State Health Services (DSHS) Commissioner.

(c) Notifications to the DSHS Commissioner must be submitted on the designated electronic form available on DSHS's School Health Program website found at dshs.texas.gov.

§40.48.Notice to Parents Regarding Unassigned Asthma Medication Policies in Schools.

(a) If a school district, open-enrollment charter school, or private school implements an unassigned asthma medication policy under this subchapter, the campus shall provide written or electronic notice to a parent or guardian of each student in accordance with Texas Education Code §38.212.

(b) If a school district, open-enrollment charter school, or private school changes or discontinues the unassigned asthma medication policy under this subchapter, written or electronic notice detailing the change or discontinuation must be provided to a parent or guardian of each student within 15 calendar days after the change or discontinuation.

§40.49.Immunity from Liability.

A person who in good faith takes or fails to take any action under this subchapter, or Texas Education Code Chapter 38 Subchapter E, is immune from civil or criminal liability or disciplinary action resulting from that action or failure to act in accordance with Texas Education Code §38.215(a).

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

Filed with the Office of the Secretary of State on October 2, 2020.

TRD-202004110

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: November 15, 2020

For further information, please call: (512) 776-7279