Title of Regulation: 12VAC5-110. Regulations for the Immunization of School Children (amending 12VAC5-110-10, 12VAC5-110-70, 12VAC5-110-80, 12VAC5-110-90).

Statutory Authority: §§ 22.1-271.2, 32.1-12, and 32.1-46 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 30, 2015.

Effective Date: January 14, 2016.

Agency Contact: James Farrell, Director, Division of Immunization, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-8055, or email james.farrell@vdh.virginia.gov.

Basis: Sections 22.1-271.2 and 32.1-46 of the Code of Virginia provide the State Board of Health with the authority to promulgate regulations regarding immunization of school children.

Purpose: Regulations are necessary to ensure children are protected to the extent possible from vaccine-preventable diseases and to protect indirectly the health of all Virginians. Recent periodic review of existing regulations identified language that is unclear or should be modified to address technological changes.

Rationale for Using Fast-Track Process: While some changes are the result of comments received during the periodic review process, additional changes are suggested to clarify issues that have been identified since the most recent amendments were enacted. None of the suggested changes will change any currently required immunizations or result in significant changes to current practice.

Substance: Amendments to the current regulations (i) update and clarify definitions; (ii) remove references to outdated versions of forms and ACIP schedules; (iii) clarify that a printout of an electronic record can be accepted without the signature of a nurse or physician; (iv) clarify that pneumococcal conjugate vaccine is not required for children enrolling in kindergarten; (v) clarify how long after the fourth birthday is allowable for those vaccines that are required to be administered on or after the fourth birthday; (vi) add mumps to the list of diseases for which demonstration of immunity is acceptable; (vii) clarify that the certificate of religious exemption must be notarized; and (viii) update responsibilities of admitting officials.

Issues: The primary advantages to the agency and the public are that current regulations ensure that children are appropriately protected to the extent possible from vaccine-preventable diseases. This also indirectly protects the health of all citizens of Virginia. Proposed changes should help clarify and simplify processes for providing and documenting immunizations required for school attendance. 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:

• Add mumps to the list of diseases for which demonstration of immunity is acceptable in lieu of a vaccine shot;

• Reduce from 30 days to 10 days the time that the admitting official from the school that a student has left must send immunization records and academic records to the student's new school;

• Update and clarify definitions;

• Remove references to outdated versions of forms and U.S. Center for Disease Control and Prevention Advisory Committee on Immunization Practices (CDC-ACIP) schedules;

• Clarify that a printout of an electronic record can be accepted without the signature of a nurse or physician;

• Clarify that pneumococcal conjugate vaccine is not required for children enrolling in kindergarten;

• Clarify how long after the fourth birthday is allowable for those vaccines that are required to be administered on or after the fourth birthday; and

• Clarify that the certificate of religious exemption must be notarized.

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

Estimated Economic Impact. The proposed updating of definitions and the various proposed language amendments to clarify current requirements will enable readers of the regulation to more accurately understand requirements in practice. Thus these proposed amendments will likely produce a small net benefit.

The CDC-ACIP has found that children who have demonstrated existing immunity to mumps are safe to be considered adequately immunized for the disease. Consequently the Board proposes to exempt students who have documentation of antibodies against mumps from the requirement for the mumps immunization shot. In order to prove immunity the child would need to have blood drawn. So for those families who choose to prove immunity rather than have the mumps shot, it will not likely significantly affect cost in time or dollars but does provide an additional option for those who wish to avoid additional vaccines. Thus, this proposed amendment will create a net benefit.

Under the current regulations, the admitting official of the school from which a student is transferring must send the 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 the student is transferring within 30 days of the transfer to the new school. The Board proposes to shorten the required time within which to send the records to 10 days. The proposed reduction in time is intended to help reduce the potential for delays in enrollment for transferring students.¹

There are no official requirements concerning notifying the old school when a student seeks to enroll in a new school.² Nevertheless, according to the Department of Education the admitting officials of the schools from which students transfer have been notified in sufficient time in practice. The 30-day deadline has been consistently met, but taking upwards of 30 days to send immunization records has in some cases delayed students' enrollment in their new school. To the extent that reducing from 30 days to 10 days the time that the admitting official from the school that a student has left must send immunization records and academic records to the student's new school would reduce enrollment delays, the proposed amendment has the potential to produce significant benefit.

In order for the proposed amendment to make a significant difference in practice, the admitting officials of the old schools will need to be notified of the student's attempt at new enrollment quickly. There are no explicit penalties for failure to meet either the 30-day or 10-day deadline; presumably admitting officials will seek to meet the deadline in effect in order to help the student in question.

Businesses and Entities Affected. The proposed regulations pertain to approximately 4200 private health care providers,³ 135 public health clinics,⁴ admitting officials at schools within the Commonwealth's 132 school districts, and students.

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

Projected Impact on Employment. The proposed amendments will not significantly affect employment.

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

Small Businesses: Costs and Other Effects. The proposed amendments will not significantly affect costs for small businesses.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed amendments will not adversely affect small businesses.

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

_______________________________

¹ Source: Virginia Department of Education

² Ibid

³ Data source: Virginia Department of Health

⁴ Ibid

Agency's Response to Economic Impact Analysis: The Department of Health concurs with the Department of Planning and Budget's economic impact analysis of 12VAC5-110.

Summary:

The amendments (i) update and clarify definitions; (ii) update the version of the U.S. Center for Disease Control and Prevention Advisory Committee on Immunization Practices schedules that is incorporated by reference; (iii) clarify that a printout of an electronic record can be accepted without the signature of a nurse or physician; (iv) clarify that pneumococcal conjugate vaccine is not required for children enrolling in kindergarten; (v) clarify how long after the fourth birthday is allowable for those vaccines that are required to be administered on or after the fourth birthday; (vi) add mumps to the list of diseases for which demonstration of immunity is acceptable; (vii) clarify that the certificate of religious exemption must be notarized; and (viii) update responsibilities of admitting officials.

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 213F 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 213F 213G, as long as the record is attached to Form MCH 213F 213G and the remainder of Form MCH 213F 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 schedule" schedules" means the schedule 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).

"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 III
Immunization Requirements

12VAC5-110-70. Immunization requirements.

Every student enrolling in a school shall provide documentary proof of adequate immunization with the prescribed number of doses of each of the vaccines and toxoids listed in the following subdivisions, as appropriate for his age according to the immunization schedule schedules. Spacing, minimum ages, and minimum intervals shall be in accordance with the immunization schedule schedules. A copy of every student's immunization record shall be on file in his school record.

1. Diphtheria Toxoid. A minimum of four properly spaced doses of diphtheria toxoid. One dose shall be administered on or after the fourth birthday and prior to entering kindergarten.

2. Tetanus Toxoid. A minimum of four properly spaced doses of tetanus toxoid. One dose shall be administered on or after the fourth birthday and prior to entering kindergarten.

3. Acellular Pertussis Vaccine. A minimum of four properly spaced doses of acellular pertussis vaccine. One dose shall be administered on or after the fourth birthday. A booster dose shall be administered prior to entering the sixth grade.

4. Poliomyelitis Vaccine. A minimum of four doses of poliomyelitis vaccine with one dose administered on or after the fourth birthday and prior to entering kindergarten.

5. Measles (Rubeola) Vaccine. One dose of live measles vaccine administered at age 12 months or older, and a second dose administered prior to entering kindergarten.

6. Rubella Vaccine. A minimum of one dose of rubella virus vaccine administered at age 12 months or older.

7. Mumps Vaccine. One dose of mumps virus vaccine administered at age 12 months or older and a second dose administered prior to entering kindergarten.

8. Haemophilus Influenzae Type b (Hib) Vaccine. A complete series of Hib vaccine (i.e., up to a maximum of four doses of vaccine as appropriate for the age of the child and the age at which the immunization series was initiated). The number of doses administered shall be in accordance with current immunization schedule recommendations. Attestation by the physician or his designee, registered nurse, or an official of a local health department on that portion of Form MCH 213G pertaining to Hib vaccine shall mean that the child has satisfied the requirements of this section. This section shall not apply to children older than 60 months of age or for admission to any grade level, kindergarten through grade 12.

9. Hepatitis B Vaccine. A minimum of three doses of hepatitis B vaccine for all children. The FDA has approved a two-dose schedule only for adolescents 11 through 15 years of age and only when the Merck brand (RECOMBIVAX HB) Adult Formulation Hepatitis B vaccine is used. The two RECOMBIVAX HB adult doses must be separated by a minimum of four months. The two dose schedule using the adult formulation must be clearly documented in the Hepatitis B section on Form MCH 213G.

10. Varicella (Chickenpox) Vaccine. All children born on and after January 1, 1997, shall be required to have one dose of chickenpox vaccine on or after 12 months of age and a second dose administered prior to entering kindergarten.

11. Pneumococcal Conjugate Vaccine (PCV). A complete series of PCV (i.e., up to a maximum of four doses of vaccine as appropriate for the age of the child and the age at which the immunization series was initiated). The number of doses administered shall be in accordance with current immunization schedule recommendations. Attestation by the physician or his designee, registered nurse, or an official of a local health department on that portion of Form MCH 213G pertaining to PCV vaccine shall mean that the child has satisfied the requirements of this section. This section shall not apply to children older than 60 months of age or for admission to any grade level, kindergarten through grade 12.

12. Human Papillomavirus (HPV) Vaccine. Three doses of properly spaced HPV vaccine for females, effective October 1, 2008. The first dose shall be administered before the child enters the sixth grade.

12VAC5-110-80. Exemptions from immunization requirements.

A. Religious and medical exemptions. No certificate of immunization shall be required of any student for admission to school if:

1. The student or his parent or guardian submits a notarized Certificate of Religious Exemption (Form CRE 1), to the admitting official of the school to which the student is seeking admission. Form CRE 1 is an affidavit stating that the administration of immunizing agents conflicts with the student's religious tenets or practices. The form is available on the Division of Immunization website at http://www.vdh.virginia.gov//Epidemiology/Immunization/requirements.htm; or

2. The school has written certification on either of the documents specified under "documentary proof" in 12VAC5-110-10 from a physician, registered nurse, or a local health department that one or more of the required immunizations may be detrimental to the student's health. Such certification of medical exemption shall specify the nature and probable duration of the medical condition or circumstance that contraindicates immunization.

3. Upon the identification of an outbreak, potential epidemic, or epidemic of a vaccine-preventable disease in a public or private school, the commissioner has the authority to require the exclusion from such school of all children who are not immunized against that disease.

B. Demonstration of existing immunity. The demonstration in a student of antibodies against rubeola mumps, measles, rubella, or varicella in sufficient quantity to ensure protection of that student against that disease, shall render that student exempt from the immunization requirements contained in 12VAC5-110-70 for the disease in question. Such protection should be demonstrated by means of a serological testing method appropriate for measuring protective antibodies against rubeola mumps, measles, rubella, or varicella respectively. Reliable history of chickenpox disease diagnosed or verified by a health care provider shall render students exempt from varicella requirements.

C. HPV vaccine. Because the human papillomavirus is not communicable in a school setting, a parent or guardian, at the parent's or guardian's sole discretion, may elect for the parent's or guardian's child not to receive the HPV vaccine, after having reviewed materials describing the link between the human papillomavirus and cervical cancer approved for such use by the board.

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 30 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 1, 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. The report for students entering the sixth grade shall include the number with a booster dose of tetanus, diphtheria, or pertussis containing vaccine within the last five years.

G. 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.

FORMS (12VAC5-110)

Certificate of Religious Exemption, CRE-1 (rev. 00/1992)

School Entrance Health Form, Health Information Form/Comprehensive Physical Examination Report/Certification of Immunization, MCH 213G (rev. 3/2014)

Student Immunization Status Report, Form SIS 3 (School) (rev. 5/2009)

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-110)

2010 Recommended Immunization Schedule for Persons Aged 0 through 6 Years, U.S. Department of Health and Human Services.

2010 Recommended Immunization Schedule for Persons Aged 7 through 18 Years, U.S. Department of Health and Human Services.

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