Epinephrine Auto-Injector Policies in Institutions of ...



00TO: Health and Human Services Commission Executive CouncilDATE:November 14, 2019 FROM:Manda Hall, MD, Associate CommissionerCommunity Health Improvement DivisionAGENDA ITEM: 2.bSUBJECT: Epinephrine Auto-Injector Policies in Institutions of Higher EducationBACKGROUND: ? Federal ? Legislative ? Other: Program InitiativeThe proposed new rules in Texas Administrative Code, Title 25, §§40.1 - 40.8, implement Senate Bill (S.B.) 1367, 85th Legislature, Regular Session, 2017, and House Bill (H.B.) 476 and H.B. 4260, 86th Legislature, Regular Session, 2019. These laws require the adoption of rules for the maintenance, administration, and disposal of epinephrine auto-injectors in institutions of higher education who voluntarily adopt unassigned epinephrine auto-injector policies. The laws require public institutions of higher education who adopt a policy to submit the policy to the Department of State Health Services (DSHS), and authorize private or independent institutions of higher education to adopt and implement epinephrine auto-injector policies. S.B. 1367 also requires the appointment of an employee of a general teaching institution and the appointment of an employee of a public junior college or a public technical institute to the DSHS Stock Epinephrine Advisory Committee, established in 2015 by Texas Education Code, Chapter 38, Subchapter E.The DSHS Stock Epinephrine Advisory Committee recommends that institutions of higher education who voluntarily adopt and implement unassigned epinephrine auto-injector policies are required to stock at least one adult pack (two doses) of epinephrine auto-injectors. Additional packs may be stocked if determined necessary based on the campus's individual assessment. Public institutions of higher education are required to report to DSHS no later than the 10th business day after the administration of an epinephrine auto-injector via the online epinephrine auto-injector reporting form. Based on the recommendations of the committee, DSHS is proposing the new rules.ISSUES AND ALTERNATIVES:There are no outstanding issues or concerns with implementation of the proposed new rules.STAKEHOLDER INVOLVEMENT:The draft new rules were sent to external stakeholders on March 4, 2019, for review. Stakeholders were asked to submit informal comments by April 18, 2019. Comments received from stakeholders were reviewed by staff and taken into consideration. External stakeholders included institutions of higher education and the Texas Medical Association. Feedback on the draft rules was positive. The proposed rules were also revised to include that epinephrine auto-injectors must be stored according to the manufacturer’s guidelines.FISCAL IMPACT:? None SERVICES IMPACT STATEMENT:The public will benefit from this proposal because the proposal will allow institutions of higher education to voluntarily adopt unassigned epinephrine auto-injector policies, allowing trained individuals to administer epinephrine auto-injectors to persons suspected of experiencing anaphylaxis.RULE DEVELOPMENT SCHEDULE:November 14, 2019Present to HHSC Executive CouncilJanuary 2020Publish proposed rules in Texas Register April 2020Publish adopted rules in Texas RegisterMay 2020Effective dateTITLE 25HEALTH SERVICESPART 1DEPARTMENT OF STATE HEALTH SERVICESCHAPTER 40EPINEPHRINE AUTO-INJECTOR AND ANAPHYLAXIS POLICIESSUBCHAPTER AEPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATIONPROPOSED PREAMBLEThe Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes new §§40.1-40.8, in new Chapter 40, Epinephrine Auto-Injector and Anaphylaxis Policies, Subchapter A, concerning Epinephrine Auto-Injector Policies in Institutions of Higher Education.BACKGROUND AND PURPOSEThe purpose of the proposed new sections is to implement Senate Bill (S.B) 1367, 85th Legislature, Regular Session, 2017, and House Bill (H.B.) 476 and H.B. 4260, 86th Legislature, Regular Session, 2019. S.B. 1367 added Texas Education Code, Chapter 51, Subchapter Y-1, which requires the adoption of rules for the maintenance, administration, and disposal of epinephrine auto-injectors in institutions of higher education who voluntarily adopt epinephrine auto-injector policies. H.B. 476 amended §51.882 of the Texas Education Code to require institutions of higher education who adopt a policy to submit the policy to DSHS. DSHS will maintain a record of the most recent policy and will make the information available upon request. H.B. 4260 added §773.0145 to the Texas Health and Safety Code, which authorizes private or independent institutions of higher education to adopt and implement epinephrine auto-injector policies. H.B. 4260 also allows a physician or person who has been delegated prescriptive authority under Chapter 157, Texas Occupations Code, to prescribe epinephrine auto-injectors in the name of an entity.S.B. 1367 also requires the appointment of an employee of a general teaching institution and an employee of a public junior college or a public technical institute to the DSHS Stock Epinephrine Advisory Committee. The committee is tasked with advising DSHS on the storage and maintenance of epinephrine auto-injectors on campuses of institutions of higher education; the training of personnel and volunteers in the administration of an epinephrine auto-injector; and a plan for one or more personnel members or volunteers trained in the administration of an epinephrine auto-injector to be on each campus.The proposed new rules set the minimum standards for institutions of higher education to follow when adopting an epinephrine auto-injector policy, based on recommendations of the DSHS Stock Epinephrine Advisory Committee. An institution of higher education that voluntarily adopts an unassigned epinephrine auto-injector policy must stock at least one unassigned adult epinephrine auto-injector pack on each campus and conduct individual campus assessments to determine if additional epinephrine auto-injectors are needed. The proposed new rules allow flexibility so that institutions of higher education may develop policies that address issues specific to each campus, including campus geography and student population size. Personnel and volunteers that are trained to administer unassigned epinephrine auto-injectors may administer an epinephrine auto-injector to a person suspected of experiencing anaphylaxis, including students, personnel, volunteers, and visitors. Public institutions of higher education that adopt epinephrine auto-injector policies are required to report the administration of an epinephrine auto-injector to DSHS within 10 business days.SECTION-BY-SECTION SUMMARYProposed new §40.1 states the purpose of the subchapter, which is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors in institutions of higher education that adopt epinephrine auto-injector policies.Proposed new §40.2 addresses institutions of higher education voluntarily adopting epinephrine auto-injector policies and states that the epinephrine auto-injector policy must comply with Texas Education Code, §51.882 or Texas Health and Safety Code, §773.0145, and this subchapter.Proposed new §40.3 defines terms used in the rules relating to the maintenance, administration, and disposal of epinephrine auto-injectors in institutions of higher education.Proposed new §40.4 states that the rules apply to any institution of higher education that chooses to adopt and implement a written policy regarding the maintenance, administration, and disposal of epinephrine auto-injectors on each institution’s campus.Proposed new §40.5 presents the minimum standards regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors in institutions of higher education. Subsection (a) addresses obtaining a prescription for at least one adult epinephrine auto-injector pack (two doses) for each institution’s campus. Subsection (a) also states that additional packs may be determined based on individual campus assessments. Subsection (a)(1) establishes what an institution may consider when performing a campus assessment. Subsection (a)(1)(A) addresses consultation with campus police, office of risk management, office of food services, office of housing, office of health services, or other departments involved with student well-being. Subsection (a)(1)(B) addresses campus geography. Subsection (a)(1)(C) addresses the size of the student population. Subsection (b) establishes the development of an epinephrine auto-injector policy. Subsection (b)(1) states that a designated campus department will coordinate and manage epinephrine auto-injector policy implementation. Subsection (b)(2) states that the policy shall include those who can be trained in the administration of an epinephrine auto-injector. Subsection (b)(3) states that the policy shall include the locations of the unassigned epinephrine auto-injectors. Subsection (b)(4) states that the policy shall include notifying local emergency medical services. Subsection (b)(5) states that the policy shall include replacing used or expired epinephrine auto-injectors as soon as reasonably possible. Subsection (c) states that the policy and locations of the unassigned epinephrine auto-injectors must be publicly available, and the unassigned epinephrine auto-injectors must be stored per the manufacturer’s guidelines. Subsection (d) states that each public institution who adopts a policy must submit the policy to DSHS according to the DSHS procedure.Proposed new §40.6(a) states that the training of institution personnel or institution volunteers must include recognizing the signs and symptoms of anaphylaxis. The training must include hands-on training. Subsection (b) addresses the training being consistent with the most recent Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs published by the U.S. Centers for Disease Control and Prevention. Subsection (c) states that the training records shall be maintained and made available upon request.Proposed new §40.7(a) states that the records relating to the implementation and administration of epinephrine auto-injector policies shall be retained, per 13 TAC §6.10. Subsection (b) states that the institution of higher education shall submit a report no later than the 10th business day after the administration of an epinephrine auto-injector to the institution and to those outlined in Texas Education Code, §51.883. Subsection (c) addresses how to submit a report to DSHS. Subsection (c) also states that this section does not apply to a private or independent institution of higher education.Proposed new §40.8 addresses the immunity from liability as outlined in Texas Education Code, §51.888 and Texas Health and Safety Code, §773.0145.FISCAL NOTEDonna 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 ERNMENT 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 a new rule;(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, because the rules do not apply to small or micro-businesses, or rural communities.LOCAL EMPLOYMENT IMPACTThe 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 COSTSManda Hall, MD, Associate Commissioner, Community Health Improvement Division, has determined that for each year of the first five years the rules are in effect, the public benefit will be that the safety of individuals with undiagnosed allergies on the campuses of institutions of higher education with unassigned epinephrine auto-injector policies will be improved.Donna Sheppard has also determined that for the first five years the rules are in effect, persons who are required to comply with the proposed rules may incur economic costs because one pack of epinephrine auto-injectors (two doses) costs between $300 and $600. Based on data from the Texas Higher Education Coordinating Board, there are 148 institutions of higher education in Texas. Each institution may have multiple campuses. Assuming each institution of higher education has only one campus and purchases one adult pack of epinephrine auto-injectors for $300, the total cost will be $44,400. If the price of each pack is $600, the total cost will be $88,800. Assuming each campus purchases one adult epinephrine auto-injector pack at the beginning of the pack's (12 - 18 month) shelf life during the start of fiscal year one, each campus will have to replace the pack within the following year (within 18 months). DSHS is assuming that the cost for the hands-on training with an epinephrine auto-injector trainer will cost $20 per person. Assuming each institution of higher education trains at least one person to administer the epinephrine auto-injector, the total cost to train one person per campus will be $2,960 each year. Therefore, depending on the cost of the epinephrine auto-injector pack, the minimum total cost of compliance of all institutions of higher education is between $47,360 and $91,760 per year ($320-620 per institution 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 an institution of higher education chooses to purchase more than one pack. Institutions of higher education may utilize free epinephrine auto-injector programs, if available.TAKINGS IMPACT ASSESSMENTDSHS 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 the School Health Program, P.O. Box 149347, MC 1945, Austin, Texas 78714-9347, or 1100 W 49th Street, Austin, TX 78756, or by email to SchoolHealth@dshs.. 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) e-mailed 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 e-mailing comments, please indicate "Comments on Proposed Rule 19R016” in the subject line.STATUTORY AUTHORITYThe new sections are authorized by Texas Education Code, Chapter 51, Subchapter Y-1, which authorizes DSHS to adopt rules with advice from the advisory committee regarding the maintenance, administration, and disposal of an epinephrine auto-injector on the campus of an institution of higher education subject to a local policy being adopted. The new sections are authorized by Texas Health and Safety Code, §773.0145, which authorizes the Executive Commissioner of the Health and Human Services Commission to adopt rules regarding the maintenance, administration, and disposal of an epinephrine auto-injector by a private or independent institution of higher education subject to a local policy being adopted. The new sections are authorized by Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code, Chapter 1001. The new sections implement Texas Government Code, §531.0055; Texas Education Code, §51.887 and Texas Health and Safety Code, Chapter 773 and Chapter 1001.This agency hereby certifies that this proposal has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.TITLE 25HEALTH SERVICESPART 1DEPARTMENT OF STATE HEALTH SERVICESCHAPTER 40EPINEPHRINE AUTO-INJECTOR AND ANAPHYLAXIS POLICIESSUBCHAPTER AEPINEPHRINE AUTO-INJECTOR POLICIES IN INSTITUTIONS OF HIGHER EDUCATION§40.1. Purpose.The purpose of this subchapter is to establish minimum standards for administering, maintaining, and disposing of epinephrine auto-injectors for an institution of higher education who adopts unassigned epinephrine auto-injector policies. These standards are implemented under Texas Education Code, Chapter 51, Subchapter Y-1 and Texas Health and Safety Code, Chapter 773, Subchapter A.§40.2. Voluntary Unassigned Epinephrine Auto-injector Policies for an Institution of Higher Education.An institution of higher education (institution) may adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors at each institution’s campus. If a written policy is adopted under this subchapter, the policy must comply with Texas Education Code, §51.882 or Texas Health and Safety Code, §773.0145, and this subchapter.§40.3. 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, as defined in Texas Education Code, §51.881, 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) Campus--An educational unit under the management and control of an institution of higher education and may include, in addition to the main campus, off-campus and secondary locations, such as branch campuses, teaching locations, regional centers, and where students are housed.(4) Institution of Higher Education--As defined in Texas Education Code, §61.003(8) and (15).(5) Personnel--Employees of an institution of higher education who are authorized and trained to administer epinephrine auto-injectors.(6) Volunteer--A person who is providing services for or on behalf of an institution of higher education on the premises of the institution’s campus, at an institution of higher education-sponsored event or an institution of higher education-related activity on or off institution property, and who does not receive compensation in excess of reimbursement for expenses and is authorized and trained to administer an epinephrine auto-injector.(7) Unassigned epinephrine auto-injector--An epinephrine auto-injector prescribed by an authorized healthcare provider in the name of the institution of higher education issued with a non-patient-specific standing delegation order for the administration of an epinephrine auto-injector, and issued by an authorized healthcare provider.§40.4. Applicability.This subchapter applies to any institution of higher education (institution) that voluntarily chooses to adopt and implement a written policy regarding the maintenance, administration, and disposal of unassigned epinephrine auto-injectors on each institution’s campus.§40.5. Maintenance, Administration, and Disposal of Unassigned Epinephrine Auto-Injectors.(a) An institution of higher education (institution) shall obtain a prescription 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 institution’s campus as described in Texas Education Code, §51.885 and Texas Health and Safety Code, §773.0145. The number of additional adult packs may be determined by an individual campus assessment led by an authorized healthcare provider, based on available resources.(1) An institution performing an assessment may consider:(A) consultation with campus police, office of risk management, office of food services, office of housing, office of health services, or any department involved with student well-being;(B) campus geography, including high risk areas; and(C) student population size.(b) In development of an epinephrine auto-injector policy, an institution shall include:(1) a designated campus department to coordinate and manage policy implementation that includes:(A) conducting an assessment; (B) training of institution personnel; (C) acquiring or purchasing, storing, and using unassigned epinephrine auto-injectors; and(D) disposing of expired unassigned epinephrine auto-injectors;(2) personnel who can be trained to administer unassigned epinephrine auto-injectors; (3) locations of unassigned epinephrine auto-injectors;(4) procedures for notifying local emergency medical services when a person is suspected of 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 or close to expiration.(c) 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.(d) Each public institution of higher education’s policy must be submitted to the Department of State Health Services (DSHS) in accordance with the DSHS procedure.§40.6. Training.(a) Each institution of higher education (institution) that adopts an unassigned epinephrine auto-injector written policy under this subchapter is responsible for training institution personnel and institution 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 institution shall maintain training records and each public institution shall make available upon request a list of those institution personnel or institution volunteers trained and authorized to administer the unassigned epinephrine auto-injector on the campus.§40.7. Report on Administering Unassigned Epinephrine Auto-Injectors.(a) Records relating to implementing and administrating the institution of higher education (institution) unassigned epinephrine auto-injector policy shall be retained per the record retention schedule for records of institutions of higher education found in 13 TAC §6.10.(b) The institution shall submit a report no later than the 10th business day after the date institution personnel or an institution volunteer administers an epinephrine auto-injector in accordance with the unassigned epinephrine auto-injector policy adopted under this subchapter. The report shall be submitted to the institution and those identified in Texas Education Code, §51.883.(c) Notifications to the commissioner of the Department of State Health Services (DSHS) shall be submitted on the designated electronic form available on DSHS’s School Health Program website found at dshs..(d) This section does not apply to a private or independent institution of higher education, as defined in Texas Education Code, §61.003(15).§40.8. Immunity from Liability.A person who in good faith takes, or fails to take, any action under this subchapter or Texas Education Code, Chapter 51, Subchapter Y-1 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 Education Code, §51.888 or Texas Health and Safety Code, §773.0145. ................
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