Title of Regulation: 12VAC5-110. Regulations for the Immunization of School Children (amending 12VAC5-110-10, 12VAC5-110-90).

Statutory Authority: §§ 22.1-271.2, 32.1-46, and 32.1-47 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: January 24, 2018.

Effective Date: February 10, 2018.

Agency Contact: Sandra Sommer, PhD, Acting Director, Division of Immunization, Virginia Department of Health, 101 North 14th Street, 15th Floor, Richmond, VA 23219, telephone (804) 864-8055, FAX (804) 864-8089, or email sandra.sommer@vdh.virginia.gov.

Basis: Statutory authority to promulgate these regulations is granted to the State Board of Health by §§ 22.1-271.2 and 32.1-46 of the Code of Virginia. Penalties are established in § 32.1-27 of the Code of Virginia.

Purpose: The regulations are amended to clarify that immunization records shall be open to inspection by health department officials. Amendments are necessary to ensure children are protected to the extent possible from vaccine-preventable diseases and to protect the health of all Virginians. School officials must comply with the law as stated in § 22.1-271.2 of the Code of Virginia in regard to inspection of immunization records by health department officials. The Virginia Department of Health (VDH) annually reviews a random sample of school immunization records to ensure compliance with current requirements. VDH would also need to review school immunization records in the event of a vaccine-preventable disease outbreak. Local health department representatives have encountered increasing resistance from school officials. Most recently, at least three of the selected 600 sites initially refused to allow records to be reviewed as part of the annual immunization survey, despite instructions to de-identify records prior to review. If the amendments are approved, failure to allow inspection of records could result in a decision to seek imposition of penalties (i.e., Class 1 misdemeanor) authorized by § 32.1-27 of the Code of Virginia.

Each year, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention (CDC) recommends changes to the immunization schedules that are subsequently published by the CDC and the American Academy of Pediatrics. The regulation is also amended to include the most recent schedules.

Rationale for Using Fast-Track Rulemaking Process: Incorporating current statutory provisions into the Virginia Administrative Code reinforces the duties of school admitting officials as currently required by law and does not change current practices.

Updating documents incorporated by reference is routine.

Substance: Amendments to the regulations (i) clarify required activities of school officials and (ii) update references to the most current version of the immunization schedule.

Issues: The primary advantages to the agency and the public are that amended regulations will help ensure that children are appropriately protected to the extent possible from vaccine preventable diseases. This also serves to protect the health of all Virginians. Proposed changes clarify processes required for immunization record review and ensure that the most current recommendations are applied. No disadvantages to the public or the Commonwealth are anticipated.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to: 1) incorporate language from § 22.1-271.2 of the Code of Virginia to clarify that each admitting official is required to allow inspection of school immunization records by officials of the Virginia Department of Health (VDH), and 2) amend the definition of "Immunization schedules" to reference 2017 Centers for Disease Control and Prevention recommended schedules.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact.

Incorporating Code of Virginia Language: Code of Virginia § 22.1-271.2 (E) states that: "Every school shall record each student's immunizations on the school immunization record. The school immunization record shall be a standardized form provided by the State Department of Health, which shall be a part of the mandatory permanent student record. Such record shall be open to inspection by officials of the State Department of Health and the local health departments."

Nevertheless, VDH reports that local health department representatives have encountered increasing resistance from some school officials. Most recently, three schools initially refused to allow records to be reviewed as part of the annual immunization survey, despite instructions to de-identify records prior to review. Access to the records by health officials help ensure that children, and adults, are appropriately protected to the extent possible from vaccine preventable diseases. VDH needs access to records in the event of a vaccine-preventable disease outbreak, as well as annually review a random sample of school immunization records to ensure compliance with current requirements. Clarifying in the regulation that the records are required by law to be open for inspection by health department officials may increase cooperation and may thus indirectly help limit the spread of disease.

The proposal to incorporate language from § 22.1-271.2 of the Code of Virginia to clarify that each admitting official is required to allow inspection of school immunization records by health department staff may encourage cooperation for a reason beyond just reminding the school officials that it is the law. Code of Virginia § 32.1-27 A states that: "Any person willfully violating or refusing, failing or neglecting to comply with any regulation or order of the Board or Commissioner or any provision of this title shall be guilty of a Class 1 misdemeanor unless a different penalty is specified."

The referenced Board is the State Board of Health; thus violating the Regulations for the Immunization of School Children constitutes a Class 1 misdemeanor. The referenced title is Title 32.1. Health, which does not include § 22.1-271.2;¹ thus failing to comply with § 22.1-271.2 in of itself does not constitute a Class 1 misdemeanor.

The Board's proposal to incorporate language from § 22.1-271.2 to clarify that each admitting official is required to allow inspection of school immunization records by officials of the VDH will affectively make failure to comply a Class 1 misdemeanor, since it would then be a violation of a State Board of Health regulation.

Amending Definition: Under the current regulation "Immunization schedules" is defined as "the 2015 Recommended Immunization Schedules for Persons Aged 0 through 18 Years developed and published by the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP)."

The Board proposes to amend 2015 to 2017. The requirements of the 2017 version are the same as in the 2015 version.² Thus amending the definition will have no impact on families seeking to meet immunization requirements.

Businesses and Entities Affected. The regulation affects the 5,012 licensed child care facilities, 1,862 public schools and an estimated 750 private schools in the Commonwealth, as well as families with children in these schools and facilities.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments would not significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments do not significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments do not adversely affect businesses.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

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¹§ 22.1-271.2 is under Title 22.1. Education.

²Source: Virginia Department of Health

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs substantially with the economic impact analysis prepared by the Department of Planning and Budget.

Summary:

The amendments incorporate language from § 22.1-271.2 of the Code of Virginia to clarify that each admitting official is required to allow inspection of school immunization records by officials of the Department of Health. An amendment also incorporates by reference the latest recommended immunization schedules.

Part I
Definitions

12VAC5-110-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Adequate immunization" means the immunization requirements prescribed under 12VAC5-110-70.

"Admit" or "admission" means the official enrollment or reenrollment for attendance at any grade level, whether full-time or part-time, of any student by any school.

"Admitting official" means the school principal or his designated representative if a public school; if a nonpublic school or child care center, the principal, headmaster or director of the school or center.

"Board" means the State Board of Health.

"Commissioner" means the State Health Commissioner.

"Compliance" means the completion of the immunization requirements prescribed under 12VAC5-110-70.

"Conditional enrollment" means the enrollment of a student for a period of 90 days contingent upon the student having received at least one dose of each of the required vaccines and the student possessing a plan, from a physician or local health department, for completing his immunization requirements within the ensuing 90 calendar days. If the student requires more than two doses of hepatitis B vaccine, the conditional enrollment period, for hepatitis B vaccine only, shall be 180 calendar days.

"Documentary proof" means an appropriately completed copy of the most current version of Form MCH 213G signed by a physician or his designee, registered nurse, or an official of a local health department. A copy of the immunization record signed or stamped by a physician or his designee, registered nurse, or an official of a local health department indicating the dates of administration including month, day, and year of the required vaccines, shall be acceptable in lieu of recording these dates on Form MCH 213G, as long as the record is attached to Form MCH 213G and the remainder of Form MCH 213G has been appropriately completed. A printout of an immunization record from the provider's electronic health record can be accepted without a signature or stamp. For a new student transferring from an out-of-state school, any immunization record, which contains the exact date (month/day/year) of administration of each of the required doses of vaccines, is signed by a physician or his designee or registered nurse, and complies fully with the requirements prescribed under 12VAC5-110-70 shall be acceptable.

"Immunization" means the administration of a product licensed by the FDA to confer protection against one or more specific pathogens.

"Immunization schedules" means the 2015 2017 Recommended Immunization Schedules for Persons Children and Adolescents Aged 0 through 18 Years or Younger developed and published by the Centers for Disease Control and Prevention (CDC), the Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP).

"Physician" means any person licensed to practice medicine in any of the 50 states or the District of Columbia.

"School" means:

1. Any public school from kindergarten through grade 12 operated under the authority of any locality within this Commonwealth;

2. Any private or religious school that offers instruction at any level or grade from kindergarten through grade 12;

3. Any private or religious nursery school or preschool, or any private or religious child care center required to be licensed by this Commonwealth;

4. Any preschool classes or Head Start classes operated by the school divisions within this Commonwealth; and

5. Any family day home or developmental center.

"Student" means any person who seeks admission to a school, or for whom admission to a school is sought by a parent or guardian, and who will not have attained the age of 20 years by the start of the school term for which admission is sought.

"Twelve months of age" means the 365th day following the date of birth. For the purpose of evaluating records, vaccines administered up to four days prior to the first birthday (361 days following the date of birth) will be considered valid.

Part IV
Procedures and Responsibilities

12VAC5-110-90. Responsibilities of admitting officials.

A. Procedures for determining the immunization status of students. Each admitting official or his designee shall review, before the first day of each school year, the school medical record of every new student seeking admission to his school, and that of every student enrolling in grade six for compliance with the requirements prescribed in 12VAC5-110-70. Such review shall determine into which one of the following categories each student falls:

1. Students whose immunizations are adequately documented and complete in conformance with 12VAC5-110-70. Students with documentation of existing immunity to mumps, measles, rubella, or varicella as defined in 12VAC5-110-80 B shall be considered to be adequately immunized for such disease.

2. Students who are exempt from the immunization requirements of 12VAC5-110-70 because of medical contraindications or religious beliefs provided for by 12VAC5-110-80.

3. Students whose immunizations are inadequate according to the requirements of 12VAC5-110-70.

4. Students without any documentation of having been adequately immunized.

B. Notification of deficiencies. Upon identification of the students described in subdivisions A 3 and 4 of this section, the admitting official shall notify the parent or guardian of the student:

1. That there is no, or insufficient, documentary proof of adequate immunization in the student's school records.

2. That the student cannot be admitted to school unless he has documentary proof that he is exempted from immunization requirements pursuant to 12VAC5-110-70.

3. That the student may be immunized and receive certification by a licensed physician, registered nurse, or an official of a local health department.

4. How to contact the local health department to receive the necessary immunizations.

C. Conditional enrollment. Any student whose immunizations are incomplete may be admitted conditionally if that student provides documentary proof at the time of enrollment of having received at least one dose of the required immunizations accompanied by a schedule for completion of the required doses within 90 calendar days, during which time that student shall complete the immunizations required under 12VAC5-110-70. If the student requires more than two doses of hepatitis B vaccine, the conditional enrollment period, for hepatitis B vaccine only, shall be 180 calendar days. If a student is a homeless child or youth and does not have documentary proof of necessary immunizations or has incomplete immunizations and is not exempted from immunization as described in 12VAC5-110-80, the school administrator shall immediately admit such student and shall immediately refer the student to the local school division liaison, who shall assist in obtaining the documentary proof of, or completing, immunizations. The admitting official should examine the records of any conditionally enrolled student at regular intervals to ensure that such a student remains on schedule with his plan of completion.

D. Exclusion. The admitting official shall, at the end of the conditional enrollment period, exclude any student who is not in compliance with the immunization requirements under 12VAC5-110-70 and who has not been granted an exemption under 12VAC5-110-80 until that student provides documentary proof that his immunization schedule has been completed, unless documentary proof that a medical contraindication developed during the conditional enrollment period is submitted.

E. Transfer of records. The admitting official of every school shall be responsible for sending a student's immunization records or a copy thereof, along with his permanent academic or scholastic records, to the admitting official of the school to which a student is transferring within 10 days of his transfer to the new school.

F. Report of student immunization status. Each admitting official shall, within 30 days of the beginning of each school year or entrance of a student, or by October 15 of each school year, file with the State Health Department through the health department for his locality, a report summarizing the immunization status of the students in his school as of the first day of school. This report shall be filed using the web-enabled reporting system or on the most current version of Form SIS, the Student Immunization Status Report, and shall contain the number of students admitted to that school with documentary proof of immunization, the number of students who have been admitted with a medical or religious exemption and the number of students who have been conditionally admitted.

G. Immunization records shall be open to inspection by health department officials.

H. Each admitting official shall ensure that the parent or guardian of a female to be enrolled in the sixth grade receives educational materials describing the link between the human papillomavirus and cervical cancer. Materials shall be approved by the board and provided to the parent or guardian prior to the child's enrollment in the sixth grade.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-110)

2015 Recommended Immunization Schedules for Persons Aged 0 through 18 Years, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, effective January 1, 2015

Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, United States 2017, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services, effective January 1, 2017