2. Welcome to the Tennessee Immunization Program 2010 Spring Review

3. Tennessee Department of Health 2010 Immunization Regulations and How to Complete the 2010 Certificate Prepared by Kelly L. Moore, MD, MPH Medical Director, Tennessee Immunization Program March 18, 2010

4. Objectives 1.Review the changes in state school and pre-school immunization regulations for each age group 2.Review how to complete a certificate

5. Immunization Requirements Last change to state requirements was 2000 Required vaccines already routinely recommended Other recommended vaccines are not less important for individual health Rules became official on December 9, 2009 Effective date for most: July 2010 New requirements address (1) diseases against which children must be immunized and (2) the proper use of the Official Immunization Certificate required by law

6. Children enrolling in child care facilities, pre-school, pre-Kindergarten: Requirements before New Rules Diphtheria-Tetanus-Pertussis (DTaP, or DT if appropriate) Poliomyelitis (IPV or OPV) Measles, Mumps, Rubella (1 dose of each, usually as MMR) Varicella (1 dose or history of disease)

7. Children enrolling in child care facilities, pre-school, pre-Kindergarten: Additional New Requirements Haemophilus influenzae type B (Hib): age < 5 years only (requirement resumed following temporary suspension due to shortage 2008-2009) Hepatitis B (HBV) (July 1, 2010) Pneumococcal conjugate vaccine (PCV): age < 5 years only (July 1, 2010). PCV 7 or 13 not specified – either accepted. Hepatitis A: 1 dose, required by 18 months of age, if enrolled before 18 months, or at enrollment if older (July 1, 2010) When requirements must be met: –All infants and children required to be up to date at enrollment –Infant enrollees are required to provide an updated certificate after completing all of the required vaccines due before age 19 months.

8. Children enrolling in Kindergarten: Before New Rules Diphtheria-Tetanus-Pertussis (DTaP, or DT if appropriate) Hepatitis B (HBV) Measles, Mumps, Rubella (2 doses of each, usually given together as MMR) Poliomyelitis (IPV or OPV) Varicella (1 dose or history of disease)

9. Children enrolling in Kindergarten: Additional New Requirements Poliomyelitis: final dose on or after the 4th birthday Varicella: 2 doses or provider-verified history of disease (July 1, 2010). –By documenting a history of disease, the provider is asserting that he or she is convinced that the child has had chickenpox –Serology result or provider-diagnosed varicella disease also accepted Hepatitis A: total of 2 doses, spaced at least 6 months apart (July 1, 2011)

10. Children entering 7 th Grade (already enrolled in a Tennessee School): Before New Rules –Hepatitis B (HBV): verify completion of series

11. Children entering 7 th Grade (already enrolled in a Tennessee School): New Rules Hepatitis B Vaccine verification no longer required for all rising 7 th graders Tetanus-diphtheria-pertussis booster (“Tdap”): (no later than October 1, 2010) –Not required if a Td booster dose administered within 5 years of 7 th grade entry is recorded on the DTaP/Td line of the certificate If Td is “remembered” but not documented, Tdap required Verification of immunity to varicella: 2 doses or provider-verified history of disease (serology or diagnosis included) (July 1, 2010)

12. New TN School Enrollees in Grades other than K and 7 th : Before New Rules Diphtheria-Tetanus-Pertussis vaccination as age appropriate Measles, Mumps, Rubella (2 doses, usually as MMR) Poliomyelitis (IPV or OPV) Varicella (1 dose or history of disease)

13. New TN School Enrollees in Grades other than K and 7 th : Additional New Rules Poliomyelitis (IPV or OPV): final dose on or after the 4th birthday now required Varicella (2 doses or provider-verified history of disease, serology or diagnosis) Hepatitis B (HBV): previously only for Kindergarten, 7th grade entry Note: Children already enrolled in a TN school simply transfer their existing certificate with them when moving to a different TN school (e.g., a child moving from a TN public middle school to a TN private high school transfers the existing TN certificate).

14. Full Time College Students: Current Requirements Documentation of 2 doses of vaccine against measles, mumps, rubella (MMR) Notes: –Applies to new full-time enrollees born in 1957 or later in higher education institutions with >200 students –Documentation is up to the school (usually on a health form): no specific state form is required

15. Full Time College Students: Additional New Requirements after July 1, 2011 Unchanged for measles, mumps, rubella (MMR) –Now specifically accept alternative (+ serology for each) Documentation of immunity to varicella –If born after 1979 only –2 doses vaccine, + serology, or history Proof of hepatitis B immunity (or disease) –Only for students in health sciences who provide patient care as part of training (before patient care begins) –Vaccine series or positive serology accepted Allows for conditional enrollment while completing vaccine series (just like grade schools) No state form: documentation is institution specific

16. Exemptions Permitted by State Law Medical (risk of harm exceeds benefit) –Specify vaccine(s) on form, other vaccines remain required. Only MD, DO or Health Department may issue a certificate with a medical exemption. Religious –No Immunization Certificate required –Parent/guardian gives written statement to school that “vaccination conflicts with their religious tenets or practices.” –If providing health exam documentation (on Certificate) to child with religious exemption, check appropriate box on form Note: Unimmunized children may be excluded from school during outbreaks of vaccine-preventable diseases

17. Minimum Ages, Dose Intervals Tennessee follows current CDC guidelines Doses are valid up to 4 days before the minimum age or dose interval (printed on back of certificate) Doses administered more than 4 days early are considered invalid and should be repeated as recommended –Most common invalid dose is MMR given >4 days before the first birthday

18. Accepted Alternatives to Immunization Positive serologic test (write in year) –Measles, Mumps, Rubella (each must be positive) –Hepatitis A –Hepatitis B –Varicella Varicella Disease (write in year) –Provider-diagnosed chickenpox or shingles –Provider-verified history (provider is convinced by description that the child had chickenpox) If the description is NOT convincing, provider may check a serology or vaccinate

19. Other Changes If a shortage of a required vaccine occurs, TDH will notify Departments of Education and Human Services of temporary suspension or change in vaccine schedule (follow CDC guidance) Resumption of schedule (in accordance with CDC guidance) will allow grace period Changes in schedules will not require regulation changes and will have published effective dates.

20. Immunization Certificate Completely new immunization certificate – 1 certificate all ages –Required if beginning pre-school or school on or after 7/1/10 –May be used if beginning daycare between April and July 1, but only current immunization requirements would apply “Yellow card” (revision date 2006) could be used until end of June, but only if beginning daycare before July 1 –Available on Immunization Registry (TWIS) by April 1 –Pre-K and K students who register without the new certificate must submit one when starting school (public school grace period until October 1) –7 th graders new certificate only required to document the new requirements (as an addendum to the old certificate) –Only TDH Official Certificate is valid (TWIS, or hard copy)

21. Georgia model For all stages: –Infant care –Older child care –Kindergarten –7 th grade –Temporary (while catching up on vaccines at any stage)

22. The Back Page: Recommended Schedule, Minimum Valid Ages and Dose Intervals, explanatory footnotes

23. Completing Certificate Demographic Data –Child Name and Birthdate –Parent/Guardian –Phone, Address Pre-printed if using TWIS to download it

24. Completing Certificate: Data Schools Need If health examination done (local school policy – not health dept.) –Date and sign or stamp (may be different provider or date than the bottom of the certificate) –Check if dental or vision screening needed (schools may provide service) –Check Religious Exemption box if health exam is completed without immunization records because parent is giving school a religious exemption statement (no special form required for religious exemption) –How do I know if exam required? Ask the parent or local school This section must be completed manually

25. Completing Certificate: Vaccination Dates Dates (mm/dd/yy) of vaccines entered here –Hib, PCV dates not required for ages 5 years or older –Measles, Mumps, Rubella separate because some may have received vaccines other than MMR (e.g., MR or separate antigens) TWIS pre-prints dates for all shots in system –If there is an error in a record printed from TWIS that you cannot correct in TWIS, write in the correction on form –Please report problem in TWIS so administrator can fix it

26. Completing Certificate: Total Doses Must be completed manually on all certificates Provider issuing certificate writes sum of doses for each vaccine in this column

27. Completing Certificate: Documenting Alternatives to Immunization Must be written manually Valid only for diseases where boxes provided - provide year (YY) Positive serology accepted: –Measles, mumps, rubella, hepatitis A or B, varicella Varicella only: –Year of provider diagnosis, or –Year of reported history (as verified by the provider)

28. Completing Certificate: Documenting Alternatives to Immunization Genuine contraindications (e.g., anaphylactic type allergy) are rare –Listed in Product Information or published on VIS Write “X” in box for each medically exempted vaccine Vaccines not exempted remain required Certificates with medical exemptions valid only if signed by a physician or health department APN, PA outside health departments may not certify medical exemptions

29. Optional Documentation Use to document the routine vaccines that are not required by the state for school / pre-school TWIS will pre-print any dates recorded in its system Gives parent record of all the child’s vaccines and raises awareness (may increase vaccination rates)

30. Completing Certificate: CRITICAL Section Where health care provider notes child’s stage of compliance with immunization requirements Complete manually for every certificate Certificate is NOT VALID if this section is blank –School sends parent back to the provider for completion

31. CRITICAL Section, Box A Temporary Enrollment when Incompletely Immunized Only used if child of any age has not completed the necessary vaccines Allows provisional enrollment while completing requirements MUST include expiration date –One calendar month after next catch-up dose due –Back side of certificate lists catch up intervals (minimum intervals)

32. CRITICAL Section, Box A Example Sue is starting Kindergarten, has vaccines except MMR. Date August 1. –Give first MMR and document it and other required vaccines –MMR catch up schedule: 2 nd MMR is due 1 month (or 4 weeks) after 1 st dose (ok to use either 28 days or 1 calendar month). You tell Mom to come back on or after September 1 –Check Box A, list expiration date of 10/01/2010 (one month later) –In September, child has second MMR dose and parent gives the school a new, complete certificate with Box D checked 10/01/2010X

33. CRITICAL Section, Box B Use Box B only under the following conditions: –18 months or younger, AND –Up to date for age, BUT not yet completed all the required doses recommended by 18 months of age (see schedule on back page) Allows enrollment while completing requirements Expires when child turns 19 months: issue new certificate with Box C Children aged 12-18 months who have completed immunizations (e.g., no more requirements until 4-6 years of age), use Box C

34. CRITICAL Section, Box B: Example 1.Alex is 6 months old and starting daycare 2.Alex has had all of his vaccines on time 3.Provider issues certificate, marks Box B, Alex enrolls 4.When Alex is 15 months, he gets his last doses required before K –In other words, his next required vaccines due after he turns 4 years –Reminder, although both doses of hepatitis A vaccine are recommended by 24 months, only 1 dose is required for child care 5.The provider can then issue an updated certificate for mom to give the daycare, with the new vaccine dates on it and marked Box C. 6.Box C is valid until Kindergarten

35. CRITICAL Section, Box C Use for child care, pre-school, pre-Kindergarten For any child age 12 months or older who has completed ALL requirements for enrolling in child care –If on schedule, requirements completed at age 12 to 18 months –No more doses would be required until entering Kindergarten Note that doses on the recommended schedule for age 4-6 years are considered Kindergarten requirements Remember that pneumococcal and Hib vaccine requirements do not apply to children on or after their 5 th birthday

36. CRITICAL Section, Box D Mark this box for children age 4 years or older who have completed all vaccine doses required for Kindergarten entry If child is a new TN enrollee in 1 st -6 th grades, mark this box if complete for those grades –Reminder that 2 doses of hepatitis A vaccine is only required for Kindergarten entry (effective July 2011), not for new enrollees in higher grades

37. CRITICAL Section: When to Check Both Boxes C&D Child has had 4 th birthday, AND Child is enrolling in pre-school / pre-K, AND Child has had all doses required for both child care and Kindergarten (usually given at age 4) Then, check Box C and Box D when issuing certificate: –Child will not need a new certificate until entering 7 th grade! X X

38. CRITICAL Section, Box E All students (including current students) entering 7 th grade If child is not a new enrollee in a TN school and already has a valid TN certificate, provider must only document compliance with Tdap and Varicella requirements –School puts new certificate with existing certificate in file New TN school enrollees in 7 th grade or higher will need documentation of all vaccines

39. Completing Certificate: Last Step Provider Contact Details and Signature/Stamp Provider’s Name, Address, Phone Provider contact details are pre-printed by TWIS Otherwise complete manually Date of issue and signature or stamped signature are required!

40. Obtaining the Official Certificate: TN Dept. of Health Form PH-4103 (rev. 3/10) Print out from TWIS https://twis.tn.gov (BEST) –Must be an authorized user (ID and password required) –No cost to join or use – view and add shot records –Records in TWIS are permanent and visible to all TWIS users –TWIS pre-populates shot, demographic and provider contact data on the certificate, minimizing completion time Health care providers licensed in TN (not parents) can obtain blank certificates from the local health department or central office to complete manually NOTE: Unofficial “mock ups” of certificates from electronic medical records are not valid

41. For More Information Immunization Program Required Vaccines Website, includes information for parents: http://health.state.tn.us/CEDS/required.htm Tennessee Web Immunization System (TWIS) includes information for health care providers: https://twis.tn.gov (Help Desk contact phone and email at website) Department of Education Coordinated School Health Program (for health examination questions) http://www.state.tn.us/education/schoolhealth/ For other vaccine questions call Tennessee Immunization Program: 1-800-404-3006 or 615-741-7247 (front desk, Communicable and Environmental Disease Services)