Title of Regulation: 12VAC5-110. Regulations for the Immunization of School Children (amending 12VAC5-110-10, 12VAC5-110-20, 12VAC5-110-30, 12VAC5-110-50, 12VAC5-110-70, 12VAC5-110-80, 12VAC5-110-90, 12VAC5-110-100, 12VAC5-110-130; repealing 12VAC5-110-140).

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

Effective Date: March 3, 2010.

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

Summary:

The amendments (i) incorporate immunization requirements enacted by the legislature, (ii) reflect changes in the current immunization schedule recommended by the American Academy of Pediatrics and the American Academy of Family Physicians, and (iii) add registered nurses to the list of entities that can administer immunizations and can provide certification that required vaccines would be detrimental to a child's health.

Changes to the proposed regulation (i) increase the minimum number of doses of polio vaccine required for school entry to four and clarify the requirement that one dose must be administered on or after the fourth birthday in order to comply with recent Advisory Committee on Immunization Practices recommendations; (ii) add family day home or developmental center to the definition of "school"; (iii) change the measles, mumps, and varicella vaccine requirements to clarify that the second dose of each vaccine must be administered prior to kindergarten entry; and (iv) change conditional enrollment to clarify that the 180-calendar-day period applies only if more than two doses of hepatitis B vaccine is required.

Summary of Public Comments and Agency's Response: A summary of comments made by the public and the agency's response may be obtained from the promulgating agency or viewed at the office of the Registrar of Regulations.

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 Form MCH 213B and the temporary certification form for Haemophilus influenzae type b disease where applicable, Form MCH 213C or a computer generated facsimile of Form 213C 213F signed by a physician or his designee, registered nurse, or an official of a local health department. The MCH 213C SUPPLEMENT 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 213C 213F, as long as the supplement record is attached to Form MCH 213C 213F and the remainder of Form MCH 213C 213F has been appropriately completed. 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 when indicated, is signed by a physician [ of 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" means the schedule 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 parochial religious school that offers instruction at any level or grade from kindergarten through grade 12;

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

4. Any preschool handicapped 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 less than 20 years of age who seeks admission to any Virginia school, or for whom admission to any Virginia school is sought by a parent or guardian 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 II
General Information

12VAC5-110-20. Purpose.

This chapter is designed to ensure that all students attending any public, private or parochial school and all attendees of licensed child care centers in the Commonwealth, are adequately immunized and protected against diphtheria, pertussis, tetanus, poliomyelitis, rubeola, rubella, mumps, haemophilus influenzae type b, and hepatitis B, varicella, pneumococcal, and human papillomavirus disease as appropriate for the age of the student.

12VAC5-110-30. Administration.

A. The Board of Health has the responsibility for promulgating regulations pertaining to the implementation of the school immunization law and standards of immunization by which a child attending a any school or child care center may be judged to be adequately immunized.

B. The State Health Commissioner is the executive officer for the State Board of Health with the authority of the board when it is not in session, subject to the rules and regulations of the board.

C. The local health director is responsible for providing assistance in implementing this chapter to the school divisions in his jurisdiction and for providing immunizations to children determined not to be adequately immunized, who present themselves to the local health department for immunization.

D. The school principals of public schools and the principals, headmasters and directors of nonpublic schools and child care centers shall require each student attending their institutions to provide documentary proof of immunization against the diseases listed in 12VAC5-110-70.

[ 12VAC5-110-50. Application of the Administrative Process Act.

The provisions of the Virginia Administrative Process Act , contained in Chapter 1.1:1 (§ 9-6.14:1 et seq.) of Title 9 of the Code of Virginia, (§ 2.2-4000 et seq. of the Code of Virginia) shall govern the adoption, amendment, modification and revision of this chapter, and the conduct of all proceedings and appeals hereunder. ]

Part III
Immunization Requirements

12VAC5-110-70. Immunization requirements.

Every new student and every child attending a licensed child care center 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. Spacing, minimum ages, and minimum intervals shall be in accordance with the immunization schedule. A copy of every student's immunization record shall be on file in his school record.

1. Diphtheria and Tetanus Toxoids and Pertussis Vaccine (DTP). For students less than seven years of age, a minimum of three doses of DTP,with one dose administered after the student's fourth birthday. If any of these three doses must be administered on or after the seventh birthday, Td (adult tetanus toxoid full dose and diphtheria toxoid reduced dose) should be used instead of DTP.

1. Diphtheria Toxoid. A minimum of four [ or more ] properly spaced doses of diphtheria toxoid. One dose shall be administered on or after the fourth birthday. A booster dose shall be administered prior to entering the sixth grade if at least five years have passed since the last dose of diphtheria toxoid.

2. Tetanus Toxoid. A minimum of four [ or more ] properly spaced doses of tetanus toxoid. One dose shall be administered on or after the fourth birthday. A booster dose shall be administered prior to entering the sixth grade if at least five years have passed since the last dose of tetanus toxoid.

3. Acellular Pertussis Vaccine. A minimum of four [ or more ] 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 if at least five years have passed since the last dose of pertussis vaccine.

2. 4. Poliomyelitis Vaccine. A minimum of [ three four ] doses of [ all trivalent oral ] poliomyelitis vaccine [ (OPV) or all inactivated polio vaccine (IPV), ] with one dose administered [ on or ] after the fourth birthday or three doses of enhanced-potency inactivated poliomyelitis vaccine (IPV), with one dose administered after the fourth birthday when OPV is contraindicated.

3. 5. Measles (Rubeola) Vaccine. For students enrolling in kindergarten or first grade on and after July 1, 1991, one One dose of live measles vaccine administered at age 12 months or older, and a second dose administered [ at four to six years of age or ] prior to entering kindergarten or first grade, whichever occurs first. The two doses must be administered at least one month apart. Students entering sixth grade on and after July 1, 1992, shall also have received two doses of live measles vaccine, with the first dose administered at age 12 months or older and the second dose at least one month after the first dose. All other students shall have received at least one dose of live measles vaccine. Any measles immunization received after 1968 should be considered to have been administered using a live virus vaccine.

4. German Measles (Rubella) 6. Rubella Vaccine. A minimum of one dose of rubella virus vaccine administered at age 12 months or older.

5. 7. Mumps Vaccine. A minimum of one One dose of mumps virus vaccine administered at age 12 months or older and a second dose administered [ at four to six years of age or ] prior to entering kindergarten. The requirement for mumps vaccine shall not apply to any child admitted for the first time to any grade level, kindergarten through grade 12 of a school prior to August 1, 1981.

6. 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 of either the American Academy of Pediatrics or those of the U.S. Public Health Service. Attestation by the physician or his designee, registered nurse, or an official of a local health department on the temporary form documenting immunizations against Hib, that portion of Form MCH 213C 213F pertaining to Hib vaccine, a computer generated facsimile of MCH 213C, or on the MCH 213C Supplement as defined in 12VAC5-110-10 under "documentary proof" shall mean that the child has satisfied the requirements of this section. This section shall not apply to children older than 30 60 months of age or for admission to any grade level, kindergarten through grade 12.

The dosage schedule for Hib vaccine varies with the manufacturer. The number of doses of vaccine required is also governed by the age at which immunization is initiated. Hence the reason why the requirements for Hib vaccine are prescribed in a manner different from those for the other vaccines.

7. 9. Hepatitis B Vaccine. A minimum of three doses of hepatitis B vaccine for all children born on or after January 1, 1994. 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 213F.

10. Varicella (Chickenpox) Vaccine. All susceptible 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 [ at four to six years of age or ] 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 213F 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 24 months of age.

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 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. For a student enrolled before July 1, 1983, any document present in the student's permanent school record claiming religious exemption shall be acceptable, 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 any 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. For a student enrolled before July 1, 1983, any document attesting to the fact that one or more of the required immunizations may be detrimental to the student's health shall be acceptable.

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 either rubeola or, 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 or, 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 measles vaccine requirements prescribed in [ subdivisions 1, 2, and 3 of ] 12VAC5-110-70 3. 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 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 12VAC5-110-90 A this section, the admitting official shall notify the student or his 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. The following table contains a suggested plan for ensuring the completion of these requirements within the 90 day conditional enrollment period. 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.

A SUGGESTED PLAN FOR ENSURING COMPLIANCE
TIME	ACTION STEP
Day 0	Conditional enrollment period starts. If student has not received first dose(s) of required vaccines, exclude student.
Day 1 to Day 42	Student should have received second dose(s) of required vaccines.
Day 43 to Day 88	Student should have received third dose(s) of required vaccines.
Day 89 and Day 90	Confirm that immunizations are completed; exclude children not in compliance.

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 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. This report shall be filed using the web-enabled reporting system or on 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.

12VAC5-110-100. Responsibilities of physicians and local health departments.

A. Documentary proof for students immunized in Virginia. Every physician, registered nurse, and local health department providing immunizations to a child shall provide documentary proof, as defined in 12VAC5-110-10, to the child or his parent or guardian of all immunizations administered.

B. Documentary proof for out-of-state students. For a student transferring from an out-of-state school to a Virginia school, the admitting official may accept as documentary proof any immunization record for that student which that is signed by a physician or [ registered ] nurse and that contains the exact date (month/day/year) of administration of each of the required doses of vaccines when indicated and which that complies fully with the requirements prescribed under 12VAC5-110-70. Any immunization record which that does not contain the signature of a physician or a nurse and does not contain the month/day/year of administration of each of the required vaccine doses shall not be accepted by the admitting official as documentary proof of adequate immunization with the exception of immunization against Hib. Such a student's record shall be evaluated by an official of the local health department who shall determine if that student is adequately immunized in accordance with the provisions of 12VAC5-110-70. Should the local health department determine that such a student is not adequately immunized, that student shall be referred to his private physician or local health department for any required immunizations.

12VAC5-110-130. Responsibility of parent to have a child immunized.

In accordance with § 32.1-46 of the Code of Virginia, "the parent, guardian or person standing in loco parentis of each child within this Commonwealth shall cause such child to be ensure such child is immunized by vaccine against diphtheria, tetanus, whooping cough and poliomyelitis and hepatitis B before such child attains the age of one year, against Haemophilus influenzae type b before he attains the age of 30 months, and against measles (rubeola), German measles (rubella) and mumps before such child attains the age of two years. All children shall also be required to receive a second dose of measles (rubeola) vaccine in accordance with the regulations of the board. The board's regulations shall require that all children receive a second dose of measles (rubeola) vaccine prior to first entering kindergarten or first grade and that all children who have not yet received a second dose of measles (rubeola) vaccine receive such second dose prior to entering the sixth grade." in accordance with the immunization schedule.

The parent or guardian of a child who is home instructed shall ensure such child is immunized in accordance with § 22.1-271.4 of the Code of Virginia.

Penalties for noncompliance shall be in accordance with § 32.1-27 of the Code of Virginia.

[ 12VAC5-110-140. General penalties. (Repealed.)

In accordance with § 32.1-27 of the Code of Virginia, "any person willfully violating or refusing, failing or neglecting to comply with any regulation or order of the board or commissioner of any provision of this title shall be guilty of a Class 1 misdemeanor unless a different penalty is specified." ]

FORMS (12VAC5-110)

Certificate of Religious Exemption, CRE 1 (Eff. CRE-1, Rev. 00/92 (eff. 7/83).

School Entrance Physical Examination and Immunization Certification, MCH-213C (Rev. 10/91) MCH 213F (rev. 04/07).

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-110)

[ 2009 2010 ] Recommended Immunization Schedule for Persons Aged 0 through 6 Years, U.S. Department of Health and Human Services.

[ 2009 2010 ] Recommended Immunization Schedule for Persons Aged 7 through 18 Years, U.S. Department of Health and Human Services.