The purpose and effect of amending these rules is to amend definitions and collection procedures for newborn screening.

 

DEPARTMENT OF HEALTH

Division of Children's Medical Services

RULE NOS.:RULE TITLES:

64C-7.001Definitions

64C-7.002Collection Procedures for Newborn Screening

PURPOSE AND EFFECT: The purpose and effect of amending these rules is to amend definitions and collection procedures for newborn screening.

SUMMARY: Rule 64C-7.001, F.A.C. provides definitions of terms as used in this chapter. Rule 64C-7.002, F.A.C. identifies and incorporates by reference those disorders that infants must be screened for and addresses procedures for collection.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

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.

RULEMAKING AUTHORITY: 383.14(2) FS.

LAW IMPLEMENTED: 383.14 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Dusty Edwards, Director, Newborn Screening Unit, at [phone] or [e-mail] or 4025 Esplanade Way, Bin A-06, Tallahassee, FL 32399-1707

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64C-7.001 Definitions.

(1) through (16), No change.

(17) “Pulse Oximeter” means a U.S. Food and Drug Administration approved instrument for use in newborns to measure the percentage of hemoglobin in the blood that is saturated with oxygen.

(17) through (21) renumbered (18) through (22) No change.

(23)(22) “Unsatisfactory blood specimen” means any of the following:

(a) A specimen card slip on which an insufficient quantity of blood is obtained.

(b) A specimen card slip on which an accurate analysis or interpretation cannot be performed due to improper collection, handling, or submission.

Rulemaking Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.01, Amended 12-5-84, Formerly 10J-8.01, Amended 3-29-92, 9-20-94, 8-14-95, 3-28-96, Formerly 10J-8.001, Amended 4-1-08, 3-26-15, Amended ________.

 

64C-7.002 Collection Procedures for Newborn Screening.

(1) No change.

(2) The infant’s blood shall be collected on a specimen card slip, DOH Form DH 677 (Revised 9/16 11/07), which is titled "Newborn Screening Specimen Collection Card" “Infant Screening Metabolic Disorders” and incorporated by reference. The form is available at https://www.flrules.org/Gateway/reference.asp?No=Ref-xxxxx. The form may also be obtained through the State Public Health Laboratory located at 1217 North Pearl Street, Jacksonville, FL 32202. Forms may also be ordered through the DOH website at http://www.floridahealth.gov/programs-and-services/childrens-health/newborn-screening/_documents/order-form-for-DH677.pdf http://www.doh.state.fl.us/Lab/PDF_Files/OrderForm_for_DH677.pdf.

(3) The laboratory order for a newborn screen may be submitted via the specimen card, DOH Form DH 677 (Revised 9/16), which is titled "Newborn Screening Specimen Collection Card" or electronically to the State Public Health Laboratory. It is the responsibility of the submitting entity to complete all data fields on the specimen card or the electronic order that are required for identification, testing, result interpretation/reporting and billing of the specimen and/or patient.

(4)(3) When a live birth occurs in a hospital, or licensed birth facility, the responsible physician or healthcare practitioner, must

(a) Ensure obtain a satisfactory blood specimen is collected prior to the infant’s discharge from care. from the hospital. The specimen shall be collected within 48 hours of birth, but no not earlier than 24 hours after birth and not before the infant has been on a protein diet for at least 24 hours.

(b) If the infant is discharged from the hospital or birth facility before 24 hours after birth, or before being on a protein diet for 24 hours, a blood specimen shall be collected before discharge and regardless, but collection a second newborn screening specimen shall be repeated after 24 hours and no later than 5 days after birth. At or before discharge, the hospital or birth facility administrator or a designee designated representative must provide a written notice to the parents, guardian, or other legally responsible party person of the requirements for the such newborn to be tested again prior to within 5 days after birth. The primary responsibility for assuring repeat testing remains with the hospital or birth facility; and

(c) A pulse oximeter device must be used to test the oxygen level in the right hand and either foot. Newborns must be at least 24 hours of age or prior to hospital discharge to obtain the oxygen level. Pulse oximetry screening results must be documented on a specimen card, DOH Form DH 677 (Revised 9/16), which is titled “Newborn Screening Specimen Collection Card” or submitted electronically to the State Public Health Laboratory. Testing procedures must be consistent with the American Academy of Pediatrics current screening algorithm.

(5) When a live birth occurs in a location outside of a licensed birth facility and the infant is not admitted to a hospital following the birth, the professional person in attendance at the birth must:

(a) Obtain a satisfactory blood specimen within 48 hours of birth, but no earlier than 24 hours after birth, and

(b) A pulse oximeter device must be used to test the oxygen level in the right hand and either foot. Newborns must be at least 24 hours of age to obtain the oxygen level. Pulse oximetry screening results must be documented on a specimen card, DOH Form DH 677 (Revised 9/16), which is titled Newborn Screening Specimen Collection Card or submitted electronically to the State Public Health Laboratory. Testing procedures must be consistent with the American Academy of Pediatrics current screening algorithm.

(4) When a live birth occurs in a facility other than a licensed hospital, the professional person in attendance at the birth must obtain a satisfactory blood specimen prior to the infant’s discharge from the facility. The specimen shall be collected not earlier than 24 hours after birth and not before the infant has been on a protein diet for at least 24 hours. If the infant is discharged from the facility before 24 hours after birth, or before being on a protein diet for 24 hours, a blood specimen shall be collected regardless, but collection shall be repeated after 24 hours and no later than 5 days after birth. At or before discharge, the facility administrator or a designated representative shall provide a written notice to the parents, guardian, or other legally responsible person of the requirements for such newborn to be tested again prior to 5 days after birth. The primary responsibility for assuring repeat testing remains with the facility.

Rulemaking Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.03, Amended 12-5-84, Formerly 10J-8.03, Amended 3-29-92, 9-20-94, 3-28-96, Formerly 10J-8.003, Amended 4-1-08, 3-26-15, Amended ________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Dusty Edwards

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, State Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 04/05/2017

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 06/02/2016