6 CCR 1009-2
Statement of Basis and Purpose and Specific Statutory Authority for Amendments to Rules and Regulations Pertaining to The Infant Immunization Program and The Immunization of Students Attending School Adopted by the State Board of Health on June 18, 2003 Basis and Purpose.
The rules are amended for several purposes. First, the Department of Health has determined that the regulation requiring vaccination with the pneumococcal conjugate vaccine for children up to 24 months of age attending day care or preschool must be changed to delay the implementation date indefinitely due to the lack of availability of the vaccine to support administration to all children eligible for publicly funded vaccine. This rule, approved by the Board of Health in June, 2002, would become effective July 1, 2003. The Advisory Committee on Immunization Practices (ACIP) published recommendations in the Morbidity and Mortality Weekly Report (MMWR) (Vol 50:(50)) on December 21, 2001, on the revised administration of the pneumococcal conjugate vaccine due to the nationwide shortage. These published recommendations are still in effect Second, the rules are modified to lift the suspension of the rule requiring the 4th and 5th DTaP as a school entry requirement. The rule would be effective September 15, 2004. According to the Centers for Disease Control and Prevention (CDC) the national supply is now adequate to reinstate this rule. By delaying the implementation date of the rule reinstatement as described, school nurses, health care providers, and parents will have one full school year to bring all students into compliance. Specific Statutory Authority. These rules are promulgated pursuant to the following statutes: Title 25, Article 1, Part 904 (1) and Title 25, Article 1, Parts 1705(5). Major Factual and Policy Issues Encountered.
In that these are not new rules being proposed, but rather modifications to existing rules, no major factual or policy issues were encountered.
Alternative Rules Considered and Why Rejected.
In that these are not new rules being proposed, but rather modifications to existing rules, alternative rules were not considered.
I. Definitions A. Emancipated student - Any student who has reached age 18; a lawfully married child of any age; a child 15 years of age or older who is managing his/her own financial affairs and who is living separate and apart from his/her parent.
B. Indigent child - Any child whose parent cannot afford to have the child immunized or if emancipated, who cannot himself/herself afford immunization and who has not been exempted.
C. College student - Any student who is enrolled for one or more classes at a college or university and who is physically present at the institution. This includes students who are auditing classes but does not include persons taking classes by correspondence only.
D. Child - Any student less than 18 years of age.
E. Parent - The person or persons with parental or decision-making responsibilities for a child.
F. School official - The school’s chief executive officer or any person designated by him/her as his/her representative.
G. Student - Any person enrolled in a Colorado school as defined in I(H).
H. School - A public, private, or parochial nursery school, day care center, child care facility, family care home, Head Start program, kindergarten, or elementary or secondary school through grade twelve, or a college or university. “School” does not include college or university courses which are offered off-campus; or are offered to nontraditional adult students, as defined by the governing board of the institution; or are offered at colleges or universities which do not have residence hall facilities.
I. In-process student - A student may be considered in-process if:
J. Dose – A measured quantity of an immunizing agent; quantity and frequency of administration determined by recognized health authorities and the manufacturer of each agent. (Partial, “split,” half or fractionated “doses” are not acceptable for certification.) K. Practitioner – A duly licensed physician or other person who is permitted and otherwise qualified to administer vaccines under the laws of this state.
L. Infant – Any child up to twenty-four months of age or any child eligible for vaccination and enrolled under the Colorado Medical Assistance Act, article 4 of title 26, C.R.S.
M. Immunization Tracking System – A comprehensive immunization tracking system established by the Department of Public Health and Environment pursuant to Section 25-4-1705(E), C.R.S.
N. Vaccines for Children (VFC) Program – A federally funded program for the purchase and distribution of pediatric vaccines to program-registered providers for the immunization of vaccine-eligible children.
O. VFC-Eligible Children – Federally purchased vaccines under the VFC Program will be made available to children who are 18 years of age or younger and who are eligible for Medicaid or who are not insured under any form of health insurance or who are not insured with respect to the vaccine and who are administered pediatric vaccines by a Federally Qualified Health Center (FQHC) or in a rural health clinic or who are American Indians/Alaskan Natives, as defined in section 4 of the Indian Health Care Improvement Act.
II. Exemptions From Immunization It is the responsibility of the parent(s) to have his or her child immunized unless the child is exempted. A student may be exempted from receiving the required immunizations in the following manner:
A. Medical exemption - By submitting to the student’s school a Certificate of Immunization with the statement of medical exemption signed by a physician licensed to practice medicine or osteopathic medicine in any state or territory of the United States indicating that the physical condition of the student is such that immunizations would endanger his/her life or health or is medically contraindicated due to other medical conditions.
B. Religious exemption - By submitting to the student’s school a Certificate of Immunization with the statement of religious exemption signed by the parent(s) or the emancipated student indicating that the parent(s) or emancipated student is an adherent to a religious belief whose teachings are opposed to immunizations.
C. Personal belief exemption - By submitting to the student’s school a Certificate of Immunization with the statement of personal exemption signed by the parent(s) or the emancipated student indicating that the parent(s) or emancipated student has a personal belief that is opposed to immunizations.
D. In the event of an outbreak of disease against which immunization is required, no exemption or exception from immunization shall be recognized and exempted persons may be subject to exclusion from school and quarantine.
E. All information distributed to the parent(s) by school districts regarding immunization shall inform them of their rights under II(A-C).
F. If the school chooses to use the immunization tracking system to monitor compliance with the school law, and the parent(s) or student submits an exemption, the school must submit the exemption information to the immunization tracking system.
G. A student who is 11 years of age or greater may be exempt from the three-dose requirement for hepatitis b vaccination if the student provides written documentation from a licensed physician that the student, when aged 11 to 15 years, has received two doses of Recombivax HB using the adult dose (1.0 ml containing 10 µg of hepatitis b surface antigen), with the second dose given 4 to 6 months after the first dose. The specific name of the vaccine, the exact dose of antigen per injection, and the dates of administration must be included as part of the documentation.
III. Minimum Immunization Requirements The immunizations required for compliance with the school entry immunization law are outlined in Tables 1 and 2. To attend school, a student must have an age- or grade-appropriate Certificate of Immunization. Initial certification does not exempt a student from meeting subsequent age or grade requirements. The minimum number of doses required by level of school/age of student are listed in Table 1. The timetable for implementation of requirements by specific grade and school year for varicella vaccine and tetanus, diphtheria, and pertussis vaccine are listed in Table 2. Grades K to 5 and Grades 6 to 12 are grouped in Table 1, but a student in a particular grade within these groups is not required to have the minimum number of doses of varicella vaccine and tetanus, diphtheria, and pertussis vaccine prior to the school year listed in Table 2.
IV. Examination and Audit of School Immunization Records The Department of Public Health and Environment’s representative shall have the right to audit and verify records to determine compliance with the law. Discrepancies found through audits shall be corrected by school officials, and any student not in full compliance shall be suspended or expelled from school according to the following rules:
A. If the parent(s) or emancipated student was informed of the deficiencies in the student’s Certificate of Immunization pursuant to paragraph I(I)(1) of the rules, the student shall be suspended or expelled pursuant to Section 25-4-907, C.R.S.
B. If the parent(s) or emancipated student was not informed by a direct personal notification of the immunizations required and alternatives for compliance with the law, the school shall notify the parent(s) or emancipated student within 7 calendar days of the finding and the student shall: a) provide proof of immunization within fourteen days, b) continue as an in-process student, c) verify that the student is exempt, or d) the student shall be suspended or expelled pursuant to Section 25-4-907, C.R.S.
V. Denial of Attendance A. A student who is: not certified, not in-process, not appropriately vaccinated for his/her age, or not exempt shall be denied attendance in accordance with the law.
B. If the student or child is attending a school which is not subject to the School Attendance Law, Section 22-33-101 et seq., C.R.S., the school officials shall take appropriate action to deny attendance to the student or child in accordance with that school’s procedures or contract with the student; the college student will not be allowed to register for the current term or session. No indigent child shall be excluded, suspended, or expelled from school unless the immunizations have been available and readily accessible to the child at public expense.
VI. Certification of Immunization A. An official Certificate of Immunization or an Alternate Certificate of Immunization that has been approved by the Department of Public Health and Environment shall include one of the following forms of documentation that include the dates and types of immunizations administered to a student or the dates and types of exemption taken:
B. Any immunization record (original or copy) provided by a physician licensed to practice medicine or osteopathic medicine in any state or territory of the United States, registered nurse, or public health official may be accepted by the school official as certification of immunization if the information is transferred to an official Certificate of Immunization and verified by the school official. The Department of Public Health and Environment shall provide guidance to schools, licensed physicians, registered nurses, and local health agencies regarding the acceptability of vaccination received outside the United States.
C. A physician, nurse, or school health authority shall sign the appropriate section of the Certificate of Immunization when the child has met all immunization requirements.
D. Schools shall have on file an official Certificate of Immunization for every student enrolled. The Certificate of Immunization will be kept apart from other school records. When a student withdraws, transfers, or is promoted to a new school, the school official shall return the Certificate of Immunization to the parent(s) or emancipated student upon request or transfer it with the student’s school records to the new school. Upon a college or university student’s request, the Certificate of Immunization shall be forwarded as specified by the student.
VII. Reporting of Statistical Information School officials shall participate in annual school assessments completed on site by the Department of Public Health and Environment staff or designated local health agency representatives. On December 1 of each school year, college and university officials shall send an Immunization Summary Report to the Department of Public Health and Environment.
VIII. Notification of Public Health Department A. Section 25-4-907, C.R.S. requires that if a child is suspended or expelled from school for failure to comply with the immunization law, the school official shall notify the state or local department of health or public health nurse who shall then contact the parent(s) or emancipated student in an effort to secure compliance so that the child may be re-enrolled in school.
B. Upon receipt of an immunization referral from the school the public health department or public health nurse shall contact the parent(s) of the referred child or the emancipated student himself/herself to offer immunization and to secure compliance with the school immunization law in order that the child may provide a completed Certificate of Immunization to the school and in the case of an expelled or suspended child, be re-enrolled in school.
IX. Purchase, Storage, and Distribution of Vaccines As necessary to comply with Section 25-4-905, C.R.S., the Department of Public Health and Environment shall assure the purchase, storage, and distribution of the vaccines included in, but not limited to, Table 1 of these rules.
X. Contract Requirements for Providers, Hospitals, and Health Care Clinics to be an Agent of the Department of Public Health and Environment for the Purposes of the Immunization Program A. To be an agent of the Department of Public Health and Environment for the purposes of administering immunizations to infants, children, and students, a provider, hospital, or health care clinic must agree to provide each patient receiving a vaccine, or the parent or legal guardian if such patient is an unemancipated minor, a copy of the currently approved vaccine information statement.
B. The Department of Public Health and Environment shall make such requirements as are necessary to assure the confidentiality and security of information in an immunization tracking system operated pursuant to Section 25-4-1705(5)(e)(I)(H), C.R.S and Section 25-4-1705(7), C.R.S.
XI. Fee for the Administration, Reporting, and Tracking of Vaccine This rule applies to immunizations that are listed in Table 1 and any other vaccine recommended by the Advisory Committee on Immunization Practices of the U.S. Department of Health and Human Services or the American Academy of Pediatrics. Such immunizations may be given either (i) by private practitioners enrolled in the VFC Program to VFC-eligibile children or (ii) by public health agencies to any infant, child, or student or (iii) by a FQHC or rural health clinic to any infant, child, or student that is VFC-eligible or not insured with respect to vaccine.
A. Private practitioners: The fee that private practitioners may charge the Medicaid program for administering, reporting, and tracking an immunization provided to a Medicaid-enrolled infant, child, or student shall be a maximum of six dollars and fifty cents per vaccine.
B. Private practitioners: For vaccine administered to VFC-eligible but non-Medicaid-enrolled infants, children, or students, a private practitioner may charge the parent up to fourteen dollars and seventy-four cents per dose.
C. Public health agencies: For vaccine administered to Medicaid-enrolled infants, children, or students, a public health agency may charge the Medicaid program two dollars per vaccine administered for administering, reporting, and tracking the immunization.
D. Public health agencies: For vaccine administered to non-Medicaid enrolled infants, children, or students, a public health agency may charge the parent up to fourteen dollars and seventy-four cents per dose.
E. A vaccine recipient may not be denied vaccine provided by the Centers for Disease Control and Prevention federal grant or the VFC Program because of inability to pay the administrative fee. Table 1. MINIMUM NUMBER OF DOSES REQUIRED FOR CERTIFICATE OF IMMUNIZATION Va Le Le Le Le Le Le Le Le Le Le Le Le cci vel vel vel vel vel vel vel vel vel vel vel vel ne of of of of of of of of of of of of a Sc Sc Sc Sc Sc Sc Sc Sc Sc Sc Sc Sch ho ho ho ho ho ho ho ho ho ho ho ool/ ol/ ol/ ol/ ol/ ol/ ol/ ol/ ol/ ol/ ol/ ol/ Ag Ag Ag Ag Ag Ag Ag Ag Ag Ag Ag Ag e of e e e e e e e e e e e Stu of of of of of of of of of of of den Stu Stu Stu Stu Stu Stu Stu Stu Stu Stu Stu t de de de de de de de de de de de nt nt nt nt nt nt nt nt nt nt nt . Chi Chi Chi Chi Chi Chi Chi Pre K Gra Gra Col ld ld ld ld ld ld ld sch Ent des des leg Car Car Car Car Car Car Car ool ry K 6 e e 2 e 4 e e e e e 2 4 to to to to 6 8 12 15 18 to to 5 12 3 5 to to to to to 4 6 5 11 mo mo 7 11 14 17 23 yrs yrs to to s s mo mo mo mo mo 10 18 s s s s s yrs yrs Per 1 2 3 3 3 4 4 4 5/4 5/4 6 c .
tus b b c d sis / Tet anu s / Di pht her ia Pol 1 2 3 3 3 3 3 3 4/3 4/3 4/3 .
io e f f f Me . . . . 1 1 1 1 2 h 2 h 2 h 2 h asl i es / Mu mp s / Ru bell a g Ha 1 2 2 3/2 3/2 3/2 3/2 3/2 . . . .
em /1 /1 /1 op hil us infl ue nza e typ e b (Hi b) j Pn 1 2 3/2 4/3 4/3 4/3 4/3 4/3 . . . .
eu /2 /2 /2 /2 /2 mo coc cal Co nju gat e He 1 2 2 2 3 3 3 3 3 3 3 .
pati tis B l Var . . . . 1 1 1 1 2 n 2 n 2 n .
icel o la m Me . . . . . . . . . . . p nin goc occ al a Vaccine doses administered ≤ 4 days before the minimum interval or age are to be counted as valid.
c For students ≥ 7 years who have not had the required number of pertussis doses, no new or additional doses are required. Any student ≥ 7 years at school entry in Colorado who has not completed a primary series of 3 appropriately spaced doses of tetanus and diphtheria vaccine may be certified after the 3rd dose of tetanus and diphtheria vaccine (or tetanus, diphtheria, and pertussis vaccine if 10 or 11 years) if it is given > 6 months after the 2nd dose.
d The student must meet the minimum prior requirement for the 4th or 5th doses of diphtheria, tetanus, and pertussis vaccine and have 1 tetanus, diphtheria, and pertussis vaccine dose.
e For polio, in lieu of immunization, written evidence of a laboratory test showing immunity is acceptable.
f Four doses of polio vaccine are required at school entry in Colorado unless the 3rd dose was given ≥ 48 months (i.e., on or after the 4th birthday) in which case only 3 doses are required. Four valid doses are a complete series regardless of age at completion. g For measles, mumps, and rubella, in lieu of immunization, written evidence of a laboratory test showing immunity is acceptable for the specific disease tested. The 1st dose of measles, mumps, and rubella vaccine must have been administered at ≥ 12 months of age (i.e., on or after the 1st birthday) to be acceptable.
h The 2nd dose of measles vaccine or measles, mumps, and rubella vaccine must have been administered at least 28 calendar days after the 1st dose. i Measles, mumps, and rubella vaccine is not required for college students born before January 1, 1957.
j The number of Hib vaccine doses required depends on the student’s current age and the age when the vaccine was administered. If any dose was given ≥ 15 months, the Hib vaccine requirement is met. For students who began the series < 12 months, 3 doses are required of which at least 1 dose must have been administered at ≥ 12 months (i.e., on or after the 1st birthday). If the 1st dose was given at 12 to 14 months, 2 doses are required. If the current age is ≥ 5 years, no new or additional doses are required. k The number of pneumococcal conjugate vaccine doses depends on the student’s current age and the age when the 1st dose was administered. If the 1st dose was administered at: (i) ≤ 6 months, 3 doses are required at 6 to 14 months and 4 doses are required at 15 to 23 months with 1 dose administered on or after the 1st birthday; (ii) 7 to 11 months, 2 doses are required at 6 to 14 months and 3 doses are required at 15 to 23 months with 1 dose on or after the 1st birthday; (iii) 12 to 23 months, 2 doses are required. If the current age is ≥ 2 years, no new or additional doses are required. l For hepatitis B, in lieu of immunization, written evidence of a laboratory test showing immunity is acceptable.
m For varicella, written evidence of a laboratory test showing immunity or a documented disease history from a health care provider is acceptable. The 1st dose of varicella vaccine must have been administered at ≥ 12 months of age (i.e., on or after the 1st birthday) to be acceptable.
n The second dose of varicella vaccine must have been administered at least 28 calendar days after the 1st dose.
o If the 1st dose of varicella vaccine was administered at ≥ 13 years, 2 doses are required, separated by a minimum of 4 to 8 weeks.
p Information concerning meningococcal disease and the meningococcal vaccine shall be provided to each new student or if the student is under 18 years, to the student’s parent or guardian. If the student does not obtain a vaccine, a signature must be obtained from the student or if the student is under 18 years, the student’s parent or guardian indicating that the information was reviewed.
Table 2. TIMETABLE FOR IMPLEMENTATION OF REQUIREMENTS FOR SELECTED IMMUNIZATIONS FOR GRADES K TO 12 Refer to Table 1 for the minimum number of doses required for a particular grade level. Table 2 shows the year of implementation for a requirement from Table 1 and is restricted to varicella vaccine dose 1 (VAR1) and dose 2 (VAR2) and tetanus, diphtheria, and pertussis vaccine (TDAP). Requirements and effective dates for other vaccines are listed in Table 1. In this table, after a vaccine is required for grades K to 12, it is no longer shown, but the requirements listed in Table 1 continue to apply. Sc Gr Gr Gr Gr Gr Gr Gr Gr Gr Gr Gr Gr Gr ho ad ad ad ad ad ad ad ad ad ad ad ad ad ol e e e e e e e e e e e e e Ye Le Le Le Le Le Le Le Le Le Le Le Le Le ar vel vel vel vel vel vel vel vel vel vel vel vel vel . K 1 2 3 4 5 6 7 8 9 10 11 12 20 V V V V V V V V . . T . .
07 A A A A A A A A D - R2 R1 R1 R1 R1 R1 R1 R1 AP 08 T D AP 20 V V V V V V V V V . T T .
08 A A A A A A A A A D D - R2 R2 R1 R1 R1 R1 R1 R1 R1 AP AP 09 T T D D AP AP 20 V V V V V V V V V V T T TD 09 A A A A A A A A A A D D AP - R2 R2 R2 R1 R1 R1 R1 R1 R1 R1 AP AP 10 T T T D D D AP AP AP 20 V V V V V V V V V V V T TD 10 A A A A A A A A A A A D AP - R2 R2 R2 R2 R1 R1 R1 R1 R1 R1 R1 AP 11 T T T T T D D D D D AP AP AP AP AP 20 V V V V V V V V V V V V .
11 A A A A A A A A A A A A - R2 R2 R2 R2 R2 R1 R1 R1 R1 R1 R1 R1 20 V V V V V V V V V V V V VA 12 A A A A A A A A A A A A R1 - R2 R2 R2 R2 R2 R2 R1 R1 R1 R1 R1 R1 (V A R1 req uir ed for to )
20 V V V V V V V . . . . . .
13 A A A A A A A - R2 R2 R2 R2 R2 R2 R2 20 V V V V V V V V . . . . .
14 A A A A A A A A - R2 R2 R2 R2 R2 R2 R2 R2 20 V V V V V V V V V . . . .
15 A A A A A A A A A - R2 R2 R2 R2 R2 R2 R2 R2 R2 20 V V V V V V V V V V . . .
16 A A A A A A A A A A - R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 20 V V V V V V V V V V V . .
17 A A A A A A A A A A A - R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 20 V V V V V V V V V V V V .
18 A A A A A A A A A A A A - R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 20 V V V V V V V V V V V V VA 19 A A A A A A A A A A A A R2 - R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 R2 (V A R2 req uir ed for to )