STATE BOARD OF HEALTH

[Filed July 2, 2019, 9:33 a.m.]

Preproposal statement of inquiry was filed as WSR 18-06-090.

Title of Rule and Other Identifying Information: Chapter 246-105 WAC, Immunization of child care and school children against certain vaccine-preventable diseases, the state board of health (board) will consider updating the rule regarding documentation of immunization status, the process for students who are in conditional status, the reference to the national immunization standards set by the advisory committee on immunization practices (ACIP), and improving clarity and usability.

Hearing Location(s): On August 14, 2019, at 1:50 p.m., at the John A. Cherberg Building, Senate Hearing Room 4, 304 15th Avenue S.W., Olympia, WA 98504.

Date of Intended Adoption: August 14, 2019.

Submit Written Comments to: Alexandra Montano, P.O. Box 47990, Olympia, WA 98504-7990, email https://fortress.wa.gov/doh/policyreview, fax 360-236-4088, by July 24, 2019.

Assistance for Persons with Disabilities: Contact Alexandra Montano, phone 360-236-4106, TTY 360-833-6388 or 711, email alexandra.montano@sboh.wa.gov, by July 24, 2019.

Purpose of the Proposal and Its Anticipated Effects, Including Any Changes in Existing Rules: The board is proposing updating the rule to improve documentation of immunization status for school and child care entry by requiring medically verified immunization records. The current rule requires parents to report their child's immunizations on the certificate of immunization status before entry into schools and child care facilities. Eliminating additional data handoffs and ensuring immunizations are medically valid will help reduce immunization documentation errors in the Washington state immunization information system.

The proposed rule clarifies the process for conditional status. The board received requests from several school nurses in 2016 asking to change the rule to require students to be fully immunized before school entry. The board decided at the time not to engage in rule making and instead suggested that board and department of health (department) staff continue the discussion with stakeholders about strategies to reduce the administrative burden to schools while decreasing the number of children who are out of compliance with school immunization requirements. The existing rule is in alignment with RCW 28A.210.080 but because there have been issues with implementation and interpretation of the current language, as demonstrated by the petitions for rule making, the proposed rule clarifies this process. In the proposed rule, students are allowed to be in conditional status for thirty days from the first day of attendance if they have received all of the doses of immunizations they are eligible for, according to the requirements established in WAC 246-105-040, on or before the first day of attendance. When the immunizations are part of a series with recommended intervals between doses, students will have thirty calendar days past the recommended date of administration of the next dose to receive the missing immunization.

The current rule includes language that requires the certificate of exemption (COE) to have a place for the parent to sign to affirm that they belong to a church or religious body that precludes a health care practitioner from providing medical treatment, and a place to identify the name of the church or religious body. The department does not collect this religious affiliation information from schools so the proposed rule removes the requirement to have the parent identify the name of the church or religious body on the COE.

EHB 1638, which passed in 2019, removes the personal and philosophical exemption for the measles, mumps, and rubella (MMR) vaccine. The proposed rule aligns the exemption requirements in the rule with the provisions of EHB 1638.

The proposed rule also updates the reference to the national immunization standards set by ACIP from the 2017 publication to the current 2019 publication.

Reasons Supporting Proposal: Updating the rule will improve immunization documentation for children entering school or child care, help schools and child cares accurately determine immunization compliance, and provide accurate information for schools and child cares to determine if a child is adequately protected in case there is an outbreak of a vaccine-preventable disease. Clarifying the process for conditional status will also decrease the administrative burden expressed by school staff to track students lacking the required immunization documentation. Finally, EHB 1638 passed during the 2019 legislative session. This bill removes the personal and philosophical exemption for the MMR vaccine and will go into effect on July 28, 2019. The proposed rule aligns the exemption requirements in the rule with the provisions of EHB 1638.

Statutory Authority for Adoption: RCW 28A.210.140.

Statute Being Implemented: RCW 28A.210.080, 28A.210.100.

Rule is not necessitated by federal law, federal or state court decision.

Name of Proponent: Washington state board of health, governmental.

Name of Agency Personnel Responsible for Drafting: Alexandra Montano, 101 Israel Road S.E., Tumwater, WA, 98504-7990, 360-236-4106; Implementation and Enforcement: Michele Roberts, 310 Israel Road S.E., Tumwater, WA 98504-7830, 360-236-3568.

A school district fiscal impact statement is not required under RCW 28A.305.135.

A cost-benefit analysis is required under RCW 34.05.328. A preliminary cost-benefit analysis may be obtained by contacting Alexandra Montano, P.O. Box 47990, Olympia, WA 98504-7990, phone 360-236-4106, fax 360-236-4088, TTY 360-833-6388 or 711, email alexandra.montano@sboh.wa.gov.

The proposed rule does not impose more-than-minor costs on businesses. Following is a summary of the agency's analysis showing how costs were calculated. There are no costs associated with the proposed rules.

AMENDATORY SECTION(Amending WSR 14-06-037, filed 2/25/14, effective 3/28/14)

WAC 246-105-020Definitions.

((For the purposes of this chapter, the words and phrases in this section have the following meanings))The definitions in this section apply throughout this chapter unless the context clearly indicates otherwise:

(1) "Certificate of exemption (COE)" means a form for the purpose of documenting an exemption to the school or child care immunization requirements that is((:

(a)))approved by the department and consistent with the requirements of WAC 246-105-050(((2); or

(b) An immunization form produced by the state immunization information system))(4).

(2) "Certificate of immunization status (CIS)" means a form for the purpose of documenting a person's immunization status that is((:

(a)))approved by the department and consistent with the requirements of WAC 246-105-050(((1); or

(b) An immunization form produced by the state immunization information system))(2).

(3) "Chief administrator" means:

(a) The person with the authority and responsibility for supervising the immediate operation of a school or child care center; or

(b) A person designated in writing by the statutory or corporate board of directors of the school district or school; or

(c) If (a) and (b) of this subsection do not apply, a person or persons with the authority and responsibility for supervising the general operation of the school district or school.

(4) "Child" means any person regardless of age admitted to:

(a) Any public school district; or

(b) Any private school or private institution subject to approval by the state board of education or described in RCW 28A.305.130 and 28A.195.010 through 28A.195.060; or

(5) "Child care center" means any facility or center licensed by the department of ((early learning))children, youth, and families under chapter ((43.215))43.216 RCW that regularly provides ((care for a group of thirteen or more children one month of age through twelve years of age))early childhood education and early learning services for a group of children for periods of less than twenty-four hours per day.

(6) "Child care health consultant" means a licensed registered nurse meeting the qualifications established in WAC 110-300-0275 or their designee.

(7) "Conditional" means a type of temporary immunization status where a child is not fully immunized against one or more of the vaccine-preventable diseases required by this chapter ((for full immunization)). A child in this status is allowed to attend a school or child care center ((provided))only if the child ((makes satisfactory progress toward full immunization))provides proof of full immunization consistent with the schedule established in WAC 246-105-060 (2)(a).

(((7)))(8) "Department" means the Washington state department of health.

(((8)))(9) "Exempt" or "exemption" means a type of immunization status where a child has not been fully immunized against one or more of the vaccine-preventable diseases required by this chapter ((for full immunization)) due to medical, religious, philosophical or personal reasons. A child in this status is allowed to attend a school or child care center only by providing the required COE form.

(((9)))(10) "Full immunization" or "fully immunized" means an immunization status where a child has provided proof of acquired immunity or has been vaccinated with immunizing agents against each of the vaccine-preventable diseases listed in WAC 246-105-030 according to the national immunization guidelines described in WAC 246-105-040.

(((10)))(11) "Health care practitioner" means a physician licensed under chapter 18.71 or 18.57 RCW, a naturopath licensed under chapter 18.36A RCW, a physician assistant licensed under chapter 18.71A or 18.57A RCW, or an advanced registered nurse practitioner licensed under chapter 18.79 RCW.

(((11)))(12) "Health care provider" means a person licensed, certified or registered in a profession listed in RCW 18.130.040(2), if administering vaccinations is within the profession's scope of practice.

(((12)))(13) "Immunizing agent" means any vaccine or other immunologic drug licensed and approved by the United States Food and Drug Administration (FDA), or meeting World Health Organization (WHO) requirements, for immunization of persons against vaccine-preventable diseases.

(((13)))(14) "Local health officer" means the individual appointed under chapter 70.05 RCW as the health officer for the local health department, or appointed under chapter 70.08 RCW as the director of public health of a combined city-county or combined county health district.

(((14)))(15) "Medically verified immunization record" means a valid record that is:

(a) An electronic or written medical health record from a health care provider or facility at which the provider practices; or

(b) A document from a secure, web-based application that records and tracks immunization dates such as an immunization registry.

(16) "National immunization guidelines" means guidelines that are:

(a) Approved by the Advisory Committee on Immunization Practices (ACIP); and

(b) Published in the Morbidity and Mortality Weekly Report (MMWR); and

(((15)))(17) "Out of compliance" means a type of immunization status where a child:

(a) Is not fully immunized for their age and grade against any of the vaccine-preventable diseases listed in WAC 246-105-030 according to the national immunization guidelines described in WAC 246-105-040; and

(b) Is not in conditional status for the missing required immunization; and

(18) "Parent" means, for the purposes of signature requirements in this rule:

(a) The mother, father, legal guardian, or any adult in loco parentis of a child less than eighteen years of age; or

(b) A person who is eighteen years of age or older and signing for themselves; or

(((16)))(19) "Religious membership" means membership in a religious body or church whose teachings or beliefs preclude a health care practitioner from providing medical treatment to the child.

(((17) "Satisfactory progress" for purposes of conditional status or an expired temporary medical exemption means the start or continuance towards full immunization status through the receipt of missing immunizations in a manner consistent with the national immunization guidelines described in WAC 246-105-040 and within the following time frames:

(a) Any missing immunizations must be received within thirty days after the first day of attendance or after a temporary medical exemption is no longer valid, unless receipt within such time is inconsistent with the guidelines.

(b) When the immunizations are part of a series with recommended intervals between doses, each additional missing immunization must be received no later than thirty days past the recommended date of administration of the next dose as established by the guidelines.

(18)))(20) "School" means a facility, site, or campus for programs of education as defined in RCW 28A.210.070 to include preschool and kindergarten through grade twelve.

(21) "School nurse" means a registered nurse licensed under chapter 18.79 RCW, or their designee, acting as the health professional in a school.

(22) "Washington state immunization information system (WAIIS)" means a statewide, secure, web-based lifetime immunization registry that tracks medically verified immunization records for people of all ages in Washington state.

(23) "WAIIS school module" means a feature of the WAIIS that allows users to track and manage medically verified student and school-level immunization information.

AMENDATORY SECTION(Amending WSR 17-16-124, filed 7/31/17, effective 8/31/17)

WAC 246-105-040Requirements based on national immunization guidelines.

The department shall develop and distribute implementation guidelines for schools and child care centers that are consistent with the national immunization guidelines described in this section and the requirements in WAC 246-105-090.

(1) Unless otherwise stated in this section, a child must be vaccinated against, or provide documentation of immunity against, each vaccine-preventable disease listed in WAC 246-105-030 at ages and intervals according to the national immunization guidelines in the "Advisory Committee on Immunization Practices (ACIP) Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger—United States, ((2017))2019"; as published in the Morbidity and Mortality Weekly Report (MMWR) ((2017;66(5):134-135))2019; 68(5):112-114.

(2) As part of the implementation guidelines, the department shall align the ages and intervals specified in the national immunization guidelines and this chapter with a corresponding grade level.

(3) In addition to the ages and intervals required by subsections (1) and (2) of this section, the following vaccine administration guidelines shall apply.

(a) Schools shall accept proof of immunization status by grade level as required by subsection (2) of this section.

(b) Schools and child care centers may accept one of the following as proof of a child's immunization status against varicella:

(((a)))(i) Documentation on the CIS form that the child received age appropriate varicella vaccine; or

(((b)))(ii) Diagnosis or verification of a history of varicella disease by a health care provider acting within ((his or her))their scope of practice; or

(((c)))(iii) Diagnosis or verification of a history of herpes zoster by a health care provider acting within ((his or her))their scope of practice; or

(((d)))(iv) Serologic proof of immunity against varicella; or

(((e)))(v) Documentation by the parent that a child has a history of varicella. This type of proof will be accepted only for certain grade levels described in the department's implementation guidelines according to WAC 246-105-090(2).

AMENDATORY SECTION(Amending WSR 14-06-037, filed 2/25/14, effective 3/28/14)

WAC 246-105-050Required documentation of immunization status.

(1) Before a child may attend a school or child care center, a parent must provide proof of immunization status using ((the following documentation:

(a) A department-approved CIS form signed by the parent. The CIS form must include:

(i)))either a CIS or a COE form. Information provided on these forms is to be used by a school nurse, child care health consultant, or the chief administrator to determine the immunization status of a child as:

(a) Fully immunized;

(b) Out of compliance;

(d) Exempt.

(2) The CIS form must be either produced from the WAIIS or a department-approved hardcopy CIS form. A hardcopy CIS form not produced from the WAIIS must include completion of the following fields:

(a) Name of child;

(((ii)))(b) Birth date;

(((iii)))(c) Type of vaccine(s) administered;

(((iv)))(d) Month, day, and year of each dose of vaccine received;

(((v)))(e) A section to indicate whether a COE form accompanies the CIS form;

(((vi)))(f) If applicable, a statement signed and dated by a parent acknowledging the requirements for their child's attendance under conditional status, which includes progress towards full immunization consistent with the schedule established in WAC 246-105-060 (2)(a);

(g) A section to document serologic proof of immunity signed by a health care provider acting within ((his or her))their scope of practice ((and including a copy of a lab report)); and

(((vii) Parent signature and date.

(b) If applicable,))(h) A statement signed and dated by a health care provider stating that the information on the CIS is accurate; or

(i) A statement signed and dated by a school nurse, child care health consultant, or the chief administrator stating that they have confirmed the accuracy of the CIS by review of the child's medically verified immunization record, and have attached the medically verified record to the CIS. For the verification to be valid the immunization record must contain:

(i) Name of child;

(ii) Birth date;

(iii) Type(s) of vaccines administered;

(iv) Month, day, and year of each vaccine administration or if applicable serologic proof of immunity verified by a health care provider acting within their scope of practice; and

(v) The name and signature of the health care provider responsible for administering or reviewing each immunization; or

(vi) A unique stamp, logo, or other information identifying the health care provider or facility at which the provider practices.

(3) Alternately, in lieu of a CIS, a school or child care center using the WAIIS school module may accept verification by school staff that the child is fully immunized as recorded in the WAIIS.

(4) A parent who seeks an exemption to the immunization requirement must provide a department-approved COE form signed by a parent. A COE form must include:

(((i)))(a) Name of child;

(((ii)))(b) Birth date;

(((iii) A place))(c) A field to indicate whether the parent is claiming a medical, religious, personal, or philosophical exemption. Philosophical and personal objections may not be used to exempt a child from measles, mumps, and rubella vaccine as described in WAC 246-105-055. This field must include:

(((A)))(i) A statement ((signed and dated by a health care practitioner))from a health care practitioner that includes the practitioner's printed name, signature, and date of signature stating that ((he or she has))they have provided the parent information about the benefits and risks of immunization to the child as a condition of obtaining a medical, religious, personal, or philosophical exemption;

(((B)))(ii) The requirement in (((b)(iii)(A)))(4)(c)(i) of this subsection does not apply to a parent who demonstrates a religious membership under subsection (((b)(iii)(F)))(4)(c)(vi) of this subsection;

(((C) A place))(iii) A field to indicate any permanent or temporary medical exemption, and if temporary, the exemption expiration date for one or more vaccines which must be signed and dated by a health care practitioner;

(((D) A place))(iv) A field to indicate any personal or philosophical exemption for one or more vaccines, except for the measles, mumps, and rubella vaccine as described in WAC 246-105-055;

(((E) A place))(v) A field to indicate any religious exemption for one or more vaccines; and

(((F) A place))(vi) A field to demonstrate religious membership. This must include a statement signed and dated by the parent ((identifying the name of the church or religious body,)) affirming membership in ((it, and affirming that the religious beliefs or))a church or religious body where the teachings of the church or religious body preclude a health care practitioner from providing medical treatment to the child;

(((iv)))(d) Notice to parents that if an outbreak of vaccine-preventable disease for which the child is exempted occurs, the child may be excluded from the school or child care center for the duration of the outbreak; and

(((v)))(e) Parent signature and date.

(((2)))(5) Parents who must include a signed statement from a health care practitioner under subsection (((1)(b)(iii)))(4)(c)(i) of this section may submit:

(a) A photocopy of the signed COE in place of the original; or

(b) Along with the COE form, a letter from the health care practitioner in ((place))lieu of the signed statement under subsection (((1)(b)(iii)))(4)(c)(i) of this section. The letter must:

(i) Indicate that the health care practitioner has provided the parent information about the benefits and risks of immunization to the child;

(ii) Reference the child's name; and

(iii) Be signed and dated by the health care practitioner.

(((3)))(6) If immunizations are deferred on a temporary basis for medical reasons under subsection (((1)(b)(iii)(C)))(4)(c)(iii) of this section, the child must ((make satisfactory progress toward))provide proof of full immunization consistent with the schedule established in WAC 246-105-060 (2)(a) once the medical exemption has expired.

WAC 246-105-055Philosophical and personal exemption for measles, mumps, and rubella vaccine prohibited.

A philosophical or personal exemption may not be used to exempt a child from the measles, mumps, and rubella immunization requirement.

AMENDATORY SECTION(Amending WSR 14-06-037, filed 2/25/14, effective 3/28/14)

WAC 246-105-060Duties of schools and child care centers.

(1) Schools and child care centers shall require on or before the first day of attendance either:

(a) A CIS or COE form ((conforming to))that documents a child's immunization status as required by WAC 246-105-050 (((1)(a))) for new enrollees registering for admission into preschool and kindergarten through grade twelve or a child care center as a requirement of admission((. Information on the CIS is used to determine if a child is fully immunized, conditional or exempt.

(b) For enrollees attending under conditional status or an expired temporary medical exemption, documentation of satisfactory progress toward full immunization.

(c) For enrollees claiming exempt status, a signed COE form indicating a medical, religious, philosophical, or personal exemption conforming to WAC 246-105-050 (1)(b)(iii) or, if applicable, WAC 246-105-050(2).

(2))); and

(b) Annually for continued enrollment in a child care center.

(2) A school nurse, child care health consultant, or chief administrator shall use information from the CIS or COE form to determine the immunization status of a child as: Fully immunized, out of compliance, conditional, or exempt.

(a) For enrollees attending under conditional status or an enrollee with an expired temporary medical exemption, the following schedule for documenting proof of full immunization applies:

(i) Any doses the child is eligible to receive based on the requirements established in WAC 246-105-040 must be administered on or before the first day of attendance. Any additional missing immunizations must be received within thirty calendar days after the first day of attendance or after a temporary medical exemption is no longer valid, unless receipt within such time is inconsistent with the national immunization guidelines; or

(ii) When the immunizations are part of a series with recommended intervals between doses, each additional missing immunization must be received no later than thirty calendar days past the recommended date of administration of the next dose as established by the national immunization guidelines.

(b) Failure to document proof of full immunization consistent with the schedule established in (a) of this subsection shall result in exclusion of a child from a school or a child care center as described in WAC 246-105-080.

(3) In maintaining child immunization records, schools and child care centers shall:

(a) Keep all department-approved forms described in WAC 246-105-050 for each enrolled child attending their school or child care ((center)).

(b) Keep ((a))or be able to produce within twenty-four hours a current list of children ((currently with medical, religious, philosophical, or personal exemptions))who are not fully immunized. This list must be transmitted to the local health department upon request.

(c) Return the applicable department-approved CIS or ((applicable)) COE or a legible copy of such documents to the parent if the child is withdrawn from a school or child care center or transferred from the school. A school or child care center may not withhold from the parent a child's department-approved CIS or COE for any reasons, including nonpayment of school or child care center fees.

(d) Provide access to immunization records to agents of the state or local health department of each child enrolled.

(((3)))(4) In maintaining child immunization records, the chief administrator shall:

(a) Retain records for at least three years on a child who is excluded from school under this chapter. The record must include the child's name, address, and date of exclusion.

(b) Submit an immunization status report under ((chapter 28A.210 RCW either electronically on the internet or on a form provided))RCW 28A.210.110 in a manner approved by the department. The report must be submitted to the department by November 1 of each year. If a school opens after October 1, the report is due thirty calendar days from the first day of school.

AMENDATORY SECTION(Amending WSR 14-06-037, filed 2/25/14, effective 3/28/14)

WAC 246-105-070Duties of health care providers or organizations.

A health care provider administering immunizations, or the organizations he or she works for, either public or private, shall furnish each person immunized, or ((his or her))their parent, with a ((written))medically verified immunization record ((of immunization)) containing information required by this chapter.

AMENDATORY SECTION(Amending WSR 09-02-003, filed 12/26/08, effective 1/26/09)

WAC 246-105-080Criteria for excluding children from schools or child care centers.

For any child excluded under subsection (1), (2), or (3) of this section, schools must use procedures consistent with chapters 180-38 and 392-380 WAC. A school or child care center shall exclude a child if one or more of the following applies:

(1) Parent(s) fail to provide ((a completed CIS form))documentation of immunization status as required in WAC 246-105-050 on or before the child's first day of attendance.

(2) A child attending under conditional status fails to make ((satisfactory)) progress toward full immunization as required in WAC 246-105-060 (2)(a).

(3) A child has been admitted under a temporary medical exemption and the particular vaccine for which the exemption was granted is no longer contraindicated and the child fails to make ((satisfactory)) progress toward full immunization as required in WAC 246-105-060 (2)(a).

(4) A local health officer excludes a child from school or a child care center under chapter 246-110 WAC during an outbreak of a vaccine-preventable disease if the child has not been fully immunized against that disease due to:

(a) Conditional status;

(b) Out of compliance status;

(((c)))(d) Religious exemption;

(((d)))(e) Philosophical exemption; or

(((e)))(f) Personal exemption.

AMENDATORY SECTION(Amending WSR 09-02-003, filed 12/26/08, effective 1/26/09)

WAC 246-105-090Implementation.

(1) The department shall develop and distribute implementation guidelines for schools and child care centers that:

(a) ((Interpret immunization requirements by grade level consistent with the ages specified in the national immunization guidelines and this chapter))Meet the requirement of WAC 246-105-040(2); and

(b) Reflect national immunization guidelines for children who did not receive required immunizations prior to entry into kindergarten or first grade, and for whom a full series of immunizations is not recommended.

(2) The department may develop school implementation guidelines that waive or modify immunization requirements when a phasing-in period is warranted for a new immunization mandate, when there is limited availability of a required immunizing agent, or when new information about the safety or efficacy of an immunizing agent prompts a reevaluation of an existing vaccination requirement. Any waiver or modification must:

(a) Reflect the best available medical research as indicated by the ACIP or the state health officer recommendation;

(b) Identify a specific vaccine-preventable disease or immunizing agent;

(d) Be limited in duration; and

(e) Be approved by the board.