The purpose of this rulemaking is to add two disorders to the newborn screening panel of disorders and incorporate the panel by reference, eliminate duplicative or unnecessary terms and rule language, and update risk screening forms.

 

DEPARTMENT OF HEALTH

Division of Children’s Medical Services

RULE NOS.:RULE TITLES:

64C-7.001Definitions

64C-7.002Collection Procedures for Newborn Screening

64C-7.0025Procedures for Newborn Screening Referral Centers

64C-7.004Designated State Laboratory

64C-7.006Newborn Screening Records

64C-7.007Criteria for Designating Newborn Screening Disorders

64C-7.008Objection to Prenatal and Infant (Postnatal) Risk Screening

64C-7.010Prenatal and Infant (Postnatal) Risk Screening Records

PURPOSE AND EFFECT: The purpose of this rulemaking is to add two disorders to the newborn screening panel of disorders and incorporate the panel by reference, eliminate duplicative or unnecessary terms and rule language, and update risk screening forms.

SUMMARY: Rule 64C-7.001, F.A.C., provides definition 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. Rule 64C-7.0025, F.A.C., provides procedures for the newborn screening centers to follow and is not statutorily supported. Rule 64C-7.004, F.A.C., states that all newborn screening laboratory tests are to be conducted by the State Public Health Laboratory and is duplicative of statute. Rule 64C-7.006, F.A.C., addresses newborn screening records and is unnecessary. Rule 64C-7.007, F.A.C., provides criteria for the designation of disorders for inclusion on the screening panel and is unnecessary. Rule 64C-7.008, F.A.C., addresses objections to prenatal and postnatal risk screening and updates or clarifies the risk screening instruments to be used. Rule 64C-7.010, F.A.C., addresses prenatal and postnatal risk screening records and has been updated to simplify language.

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 or regulatory costs in excess of $1 million within five years as established in Section 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: Whitney Jones at [phone] or [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64C-7.001 Definitions.

(1) “Advisory councils” means the Genetics and Newborn Screening Advisory Council established by Section 383.14, F.S.

(2) through (3) renumbered (1) through (2) No change.

(3)(4) “Congenital disorder” means a disorder existing before or at birth, regardless of cause, that is designated by the department in accordance with Rule 64C-7.007, F.A.C.

(5) through (8) renumbered (4) through (7) No change.

(8)(9) “Healthy Start services” mean those services provided to participants that maximize access to and participation in comprehensive prenatal and infant health care such as client and participant identification (case finding), care coordination, childbirth education, parenting education and support, nutritional counseling, psychosocial counseling, smoking cessation counseling, breastfeeding education and support, and other services that optimize health and developmental outcomes and improve access to care. Home visiting is a strategy for providing Healthy Start services. In addition to the home, Healthy Start services can also be provided in the neighborhood, school, workplace, or clinic; wherever the concerns, priorities, and resources of the participant or family can best be met. Healthy Start Coalitions have the responsibility to assess the maternal and infant health needs and services neceesary to authority to determine which specific Healthy Start services will have the greatest impact on pregnancy, health and developmental outcomes in their geographic regions.

(10) through (13) renumbered (9) through (12) No change.

(13)(14) “Newborn screening disorder” means a disorder designated by the department in accordance with Rule 64C-7.007, F.A.C., which may have pathologic consequences at birth or later in life.

(14)(15) “Newborn screening” means a procedure requiring the use of selected laboratory criteria capable of detecting the presumptive presence of disorders designated in accordance with Rule 64C-7.007, F.A.C.

(16) through (17) renumbered (15) through (16) No change.

(18) A “Newborn Screening Referral Center” is a center designated by the Florida Department of Health Children’s Medical Services Central Office to which newborns with presumptive positive screening results are referred by the department. These centers must have the professional capabilities to confirm the diagnosis, initiate and monitor therapy, and provide counseling to the families of children with presumptive positive screening results.

(19) through (22) renumbered (17) through (20) No change.

(21)(23) “Screening test” means a non-diagnostic laboratory procedure that is capable of detecting the presumptive presence of those disorders incorporated by reference in subsection 64C-7.002(1), F.A.C. phenylketonuria, congenital hypothyroidism, galactosemia, congenital adrenal hyperplasia, hemoglobin sickle beta-thalassemia, hemoglobin sickle cell disease, sickle cell anemia, 3-methylcrotonyl-CoA carboxylase deficiency, 3-OH 3-CH3 glutaric acuduria, arginosuccinic acidemia, mitochondrial acetoacetyl-CoA thiolase (betaketothiolase) deficiency, citrullinemia, glutaric acidemia type I, homocystinuria, isovaleric acidemia, long-chain L-3-OH acyl-CoA dehydrogenase deficiency, maple syrup urine disease, medium chain acyl-CoA dehydrogenase deficiency, methylmalonic acidemia, propionic acidemia, tyrosinemia type I, very long-chain acyl-CoA dehydrogenase deficiency, carnitine/acylcarnitine translocase deficiency, carnitine palmityl transferase deficiency type I, carnitine palmityl transferase deficiency type II, multiple acyl-CoA dehydrogenase deficiency, short chain acyl-CoA dehydrogenase  deficiency, tyrosinemia type II, biotinidase deficiency, carnitine uptake defect, methylmalonic acidemia (mutase deficiency), multiple carboxylase deficiency, trifunctional protein deficiency and cystic fibrosis, that shall be prescribed by the department as recommended by the American College of Medical Genetics after consultation with the Genetics and Newborn Screening Advisory Council in accordance with Rule 64C-7.007, F.A.C.

(22)(24) No change.

Rulemaking Specific 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,__________.

 

64C-7.002 Collection Procedures for Newborn Screening.

(1) Each live born infant shall be screened for those core and secondary conditions listed in the “Newborn Screening Disorders,” (12/17/2013), phenylketonuria, congenital hypothyroidism, galactosemia, congenital adrenal hyperplasia, hemoglobin sickle beta-thalassemia, hemoglobin sickle cell disease, sickle cell anemia, 3-methylcrotonyl-CoA carboxylase deficiency, 3-OH 3-CH3 glutaric acuduria, arginosuccinic acidemia, mitochondrial acetoacetyl-CoA thiolase (betaketothiolase) deficiency, citrullinemia, glutaric acidemia type I, homocystinuria, isovaleric acidemia, long-chain L-3-OH acyl-CoA dehydrogenase deficiency, maple syrup urine disease, medium chain acyl-CoA dehydrogenase deficiency, methylmalonic acidemia, propionic acidemia, tyrosinemia type I, very long-chain acyl-CoA dehydrogenase deficiency, carnitine/acylcarnitine translocase deficiency, carnitine palmityl transferase deficiency type I, carnitine palmityl transferase deficiency type II, multiple acyl-CoA dehydrogenase deficiency, short chain acyl-CoA dehydrogenase  deficiency, tyrosinemia type II, biotinidase deficiency, carnitine uptake defect, methylmalonic acidemia (mutase deficiency), multiple carboxylase deficiency, trifunctional protein deficiency, and cystic fibrosis, as recommended by the American College of Medical Genetics after consultation with the Genetics and Newborn Screening Advisory Council in accordance with Rule 64C-7.007, F.A.C., unless the parent or guardian objects to the screening in accordance with Section 383.14(4), F.S. The “Newborn Screening Disorders,” (12/17/2013) is incorporated by reference and available at ________.

(2) through (4) No change.

(5) If a newborn requires neonatal intensive care services, the responsible physician must obtain a satisfactory blood specimen on admission to the Neonatal Intensive Care Unit (NICU), prior to any blood transfusion, and again at seven days of age or just prior to discharge from the NICU, whichever is sooner. If the newborn stays in the NICU for 21 days or longer, a third specimen shall be obtained prior to discharge. If a satisfactory blood sample is not collected prior to receiving a blood transfusion, then a repeat screening specimen must be collected 3-4 months after the last blood transfusion.

Rulemaking Specific 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,__________.

 

64C-7.0025 Procedures for Newborn Screening Referral Centers.

Rulemaking Specific Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 4-1-08, Repealed__________.

 

64C-7.004 Designated State Laboratory.

Rulemaking Specific Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.05, Amended 12-5-84, Formerly 10J-8.05, Amended 3-29-92, Formerly 10J-8.005, Amended 4-1-08, Repealed__________.

 

64C-7.006 Newborn Screening Records.

Rulemaking Specific Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 10-25-79, Formerly 10D-76.07, Amended 12-5-84, Formerly 10J-8.07, Amended 3-29-92, Formerly 10J-8.007, Amended 4-1-08, Repealed__________.

 

64C-7.007 Criteria for Designating Disorders.

Rulemaking Specific Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 12-5-84, Formerly 10J-8.08, Amended 3-29-92, Formerly 10J-8.008, Repealed              __________.

 

64C-7.008 Objection to Prenatal and Infant (Postnatal) Risk Screening.

(1) The health care provider shall request any pregnant woman who objects to prenatal risk screening, after the purpose of the screening has been fully explained, to indicate her objection in writing on the screening instrument, and to sign the instrument. The screening instrument to be used is the Healthy Start Prenatal Risk Screen Screening Instrument, DOH Form 3134, 04/08 2/01 (English version), or DOH Form 3134 H, 04/08 2/01 (Creole version), or DOH Form 3134 S, 04/08 2/01 (Spanish version), which are incorporated by reference and available at__________. Copies of the Healthy Start Prenatal Risk Screening Instrument can be obtained by writing to: the Office of Maternal and Child Health, Bin A-13 (HSFFM), 4052 Bald Cypress Way, Tallahassee, FL 32399-1723. If the woman refuses to sign the instrument, this refusal shall be indicated on the patient’s signature line. The provider is to complete, the demographic items (name, address, phone number and type of provider) in the provider section and sign, and date the form.

(2) The hospital provider shall request any parent or guardian who objects to infant (postnatal) risk screening of their child or ward, after the purpose of the screening has been fully explained, to indicate the objection in writing on the electronic birth record risk screening instrument. The provider shall request any parent or guardian who objects to infant (postnatal) risk screening of their child or ward, after the purpose of the screening has been fully explained, to indicate the objection in writing on the screening instrument, and to sign the instrument. The screening instrument to be used is the Healthy Start Infant (Postnatal) Risk Screening Instrument, DOH Form 3135, 2/01 (English version), or DOH Form 3135 H, 2/01 (Creole version), or DOH Form 3135 S, 2/01 (Spanish version), which are incorporated by reference. Copies of the Healthy Start Infant (Postnatal) Risk Screening Instrument can be obtained by writing to: the Office of Maternal and Child Health, Bin A-13 (HSFFM), 4052 Bald Cypress Way, Tallahassee, FL 32399-1723. If the parent or guardian refuses to sign the instrument, this refusal shall be indicated on the patient’s signature line. The provider is to complete the demographic items (name, address, phone number and type of provider) in the provider section and sign and date the form.

(3) Out-of-hospital birth providers with access to the electronic birth record risk screening instrument shall request any parent or guardian who objects to infant (postnatal) risk screening of their child or ward, after the purpose of the screening has been fully explained, to indicate the objection in writing on the electronic birth record risk screening instrument. Out-of-hospital birth providers without access to the electronic birth record risk screening instrument shall request any parent or guardian who objects to infant (postnatal) risk screening of their child or ward, after the purpose of the screening has been fully explained, to indicate the objection in writing on Infant Risk Screen, DOH Form 3135, 01/12 (English version), or DOH Form 3135 H, 01/12 (Creole version), or DOH Form 3135 S, 01/12 (Spanish version), which are incorporated by reference and available at__________. If the parent or guardian refuses to sign the instrument, this refusal shall be indicated on the patient’s signature line. The provider is to complete, sign, and date the form.

(3)(4) No change.

Rulemaking Specific Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 3-29-92, Amended 8-14-95, 3-28-96, Formerly 10J-8.009, Amended 5-2-01, 9-11-01,__________.

 

64C-7.010 Prenatal and Infant (Postnatal) Risk Screening Records.

(1) Prenatal Risk Screening Records

(a) The health care provider shall maintain a completed copy of the Healthy Start Prenatal Risk Screen Screening Instrument in the pregnant woman’s women’s medical record.

(b) through (c) No change.

(2) Infant (Postnatal) Risk Screening Records.

(a) The health care provider shall assure that documentation of the infant’s risk screening factors is included a completed copy of the Healthy Start Infant (Postnatal) Risk Screening Instrument is placed in the infant’s medical record.

(b) The provider of care coordination shall initiate documentation on every Healthy Start infant. That documentation shall contain, at a minimum, the infant’s risk factors and the record of case disposition a scored infant (postnatal) risk screening instrument and record of case disposition, except for participants who are referred based on other factors subsequent to the initial screen. For those participants, documentation in the record shall include documentation of the participant’s risk factors and the record of case disposition.

(c) No change.

Rulemaking Specific Authority 383.14(2) FS. Law Implemented 383.14 FS. History–New 3-29-92, Amended 9-20-94, 8-14-95, 3-28-96, Formerly 10J-8.012, Amended 5-2-01,__________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Lois Taylor

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, MD, FACS, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 20, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: February 25, 2014