Notice of Proposed Rule

DEPARTMENT OF HEALTH
Division of Disease Control
RULE NO: RULE TITLE
64D-3.046: Immunization Requirements: Public and Nonpublic Schools, Grades Preschool, and Kindergarten Through 12, and Adult Education Classes
PURPOSE AND EFFECT: The Bureau of Immunization proposes an amendment to update forms and guidelines that are incorporated by reference.
SUMMARY: This rule amendment updates forms DH-680, Florida Certification of Immunization, DH Form 1479, Authorized Private Provider User Agreement For Access to Florida SHOTS, DH Form 2115, Authorized School and Licensed or Registered Child Care Facility User Agreement for Access to Florida SHOTS, and DH Form 150-615, Immunization Guidelines – Florida Schools, Child Care Facilities and Family Day Care Homes.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 381.0011(13), 381.003(1),(2), 381.005(2), 1003.22 FS.
LAW IMPLEMENTED: 381.0011(4), 381.003(1), 381.005(1)(i), 1003.22 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE,TIME AND PLACE SHOWN BELOW(IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):
DATE AND TIME: June 12, 2007, 10:00 a.m. (EDT)
PLACE: 2585 Merchants Row Blvd., Tallahassee, FL 32399-1719
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan Lincicome, Senior Management Analyst Supervisor, Department of Health, Bureau of Immunization, 2585 Merchants Row Blvd., Room 210N, Tallahassee, FL 32399-1719

THE FULL TEXT OF THE PROPOSED RULE IS:

64D-3.046 Immunization Requirements: Public and Nonpublic Schools, Grades Preschool, Kindergarten Through 12, and Adult Education Classes.

(1)(a) Immunization and Documentation Requirements –

(b) A student may attend a public or non-public school, grades preschool through 12 or an adult education class if younger than 21, if prior to admittance, attendance or transfer, they present one of the following for inspection for validity by an authorized school official:

1. DH Form 680, Florida Certification of Immunization (January 2007), (July 2001), incorporated by reference, available from the Department of Health (DOH) county health departments (CHD) or physicians’ offices.

2. Documentation of receipt of or exemption from must be noted for the following immunizations: diphtheria, tetanus, pertussis, poliomyelitis, measles (rubeola), rubella, mumps, varicella and hepatitis B. The manner and frequency of administration of the immunizations shall conform to recognized standards of medical practice.

(2) Specific immunization requirements by grade, in addition to those in paragraph (1)(a), which must be documented prior to admittance, attendance or transfer:

(a) Preschool – Completion of Haemophilus influenzae type b vaccination.

(b) Preschool or kindergarten effective with the 2001/2002 school year – completion of varicella vaccination. Each subsequent year thereafter, the next highest grade will be included in the requirement, so that students transferring into Florida schools are added to the varicella immunized cohort.

1. 7th Grade – Completion of a tetanus-diphtheria booster.

2. Additional Documentation Requirements for Exemptions.

3. For exemption from the rubeola immunization the practitioner must include with DH Form 680, Florida Certification of Immunization, incorporated by reference in subsection 64D-3.046(1), F.A.C., documentation on their own stationery of the physician’s request for exemption, asserting that the student had an illness comprised of a generalized rash lasting three or more days, a fever of 101 degrees Fahrenheit or greater, a cough, and/or coryza, and/or conjunctivitis and, in the physician’s opinion, has had the ten-day measles (rubeola) or serologic evidence of immunity to measles.

(c) Forms are to be fully executed by a practitioner licensed under Chapters 458, 459, 460, F.S., or their authorized representative (where permitted in the particular certification) per instructions for the appropriate school year, as provided in DH Form 150-615, Immunization Guidelines – Florida Schools, Child Care Facilities and Family Day Care Homes (March 2007), (July 2002), incorporated by reference, available online at: www.doh.state.fl.us/disease_ctrl/immune/schoolguide.pdf.

(d) Florida SHOTS (State Health Online Tracking System) Electronically Certified DH Form 680 produced by a CHD or a physician’s office, as provided in (7), may be utilized.

(e)(d) DH Form 681, Religious Exemptions for Immunizations (English/Spanish/Haitian-Creole) (February 2002), incorporated by reference, available at DOH CHDs, must be issued and signed by the local county health department medical director or designee.

(f)(e) Otherwise, required immunizations not performed must be accounted for under the Temporary or Permanent Medical Exemptions, DH Form 680, Florida Certification of Immunization, Parts B and C, incorporated by reference in subsection 64D-3.046(1), F.A.C.

(3) Documentation Requirements for Schools:

(a) The original of the form(s) required under subsection paragraph (1)(a) shall remain in the student’s cumulative health record.

(b) Antigen doses by dates of immunization shall be transferred as data elements through the Florida Automated System for Transferring Education Records (FASTER).

(c) Compliance Reporting:

1.   Each public and nonpublic school with a kindergarten and/or seventh grade shall submit an annual compliance report. The report shall be completed on DH Form 684, Immunization Annual Report of Compliance for Kindergarten and Seventh Grade (January 2007), (November 1996), incorporated by reference, available at DOH CHDs. The report shall include the immunization status of all children who were attending kindergarten and seventh grades at the beginning of the school year. The report shall be forwarded to the CHD director/administrator no later than October 1 of each school year, where the data will be compiled on DH Form 685, Kindergarten and Seventh Grade Annual Report of Compliance County Summary (November 2006), incorporated by reference, available at DOH CHDs; or electronically generated by the Department of Education.

2.   After consultation with the Department of Education, the DOH shall require compliance reports from public and nonpublic schools and preschools for selected grades (K-12 and preschool) in special situations of vaccine-preventable disease outbreak control or identified need for monitoring through surveys for immunization compliance levels. Such reports shall include the status of all children who were attending school at the beginning of the school year. Reports shall be forwarded to the CHD director/administrator within a specified period, as determined by the DOH.

(4) Homeless, Transfers and Juvenile Justice – A temporary exemption to requirements of subsection (2) above, not to exceed 30 days, may be issued by an authorized school official for any of the following, consistent with the definitions in Section 1003.01, F.S.:

(a) A homeless child.

(b) A transfer student.

(c) A student who enters a juvenile justice education program or school.

(5) Notwithstanding subsection (2), the Department may:

(a) Designate any required immunization as unnecessary or hazardous, according to recognized standards of medical practice.

(b) Upon determination that a shortage of vaccine exists, approve issuance of temporary medical exemption with extended expiration dates by practitioners or authorized school officials until such time as, in the DOH’s opinion, vaccine will be available in sufficient quantity for such deferred vaccinations to be completed.

(6) Florida SHOTS Opt Out Provision – Parents or guardians may elect to decline participation in the Florida immunization registry, Florida SHOTS, by submitting a Florida SHOTS Notification and Opt Out Form to the DOH. The form, either a DH Form 1478 (English) or DH Form 1478S (Spanish) or DH Form 1478H (Haitian-Creole), incorporated by reference, is available from the DOH, Bureau of Immunization, 4052 Bald Cypress Way, Bin #A-11, Tallahassee, FL 32399-1719. The immunization records of children whose parents choose to opt out will not be shared with other entities that are allowed by law to have access to children’s immunization records via authorized access to Florida SHOTS.

(7) Florida SHOTS Private Provider Participation – Any healthcare practitioner licensed in Florida under Chapter 458, 459 or 464, F.S., may request authorization to access Florida SHOTS by filling out a DH Form 1479, Authorized Private Provider User Agreement for Access to Florida SHOTS (January 2007), (November 2000), incorporated by reference, available from the DOH, Bureau of Immunization, 4052 Bald Cypress Way, Bin #A-11, Tallahassee, FL 32399-1719. The DH Form 1479 will be returned to the DOH for processing and authorization to access Florida SHOTS. Notification of access approval and instructions for accessing Florida SHOTS will be provided by the DOH. The authorized user and the applicable licensing authority or agency shall notify the DOH, Bureau of Immunization Florida SHOTS personnel when an authorized user’s license or registration has expired or has been suspended or revoked.

(8) Florida SHOTS School and Licensed or Registered Child Care Facility Participation – Any public or nonpublic school, or licensed or registered child care facility may request authorization to access Florida SHOTS by completing a DH Form 2115, Authorized School and Licensed or Registered Child Care Facility User Agreement for Access to Florida SHOTS (January 2007), (November 2000), incorporated by reference, available from the DOH, Bureau of Immunization, 4052 Bald Cypress Way, Bin #A-11, Tallahassee, FL 32399-1719. The DH Form 2115 will be returned to the DOH for processing and authorization to access Florida SHOTS. Notification of access approval and instructions for accessing Florida SHOTS will be provided by the DOH. The authorized user and the applicable licensing authority or agency shall notify the DOH, Bureau of Immunization Florida SHOTS personnel when an authorized user’s license or registration has expired or has been suspended or revoked.

Specific Authority 381.0011(13), 381.003(1),(2), 381.005(2), 1003.22 FS. Law Implemented 381.0011(4), 381.003(1), 381.005(1)(i), 1003.22 FS. History–New 11-20-06, Amended________.

Editorial Note: Formerly 10D-3.88, 10D-3.088 and 64D-3.011


NAME OF PERSON ORIGINATING PROPOSED RULE: Charles H. Alexander, Chief, Bureau of Immunization
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Russell W. Eggert, M.D., M.P.H., Director, Division of Disease Control
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: May 4, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: April 6, 2007