Division of Children's Medical Services
RULE NOS.:RULE TITLES:
64C-6.001Definitions - General
64C-6.002Standards - General
64C-6.003Standards - Specific
NOTICE OF CHANGE
Notice is hereby given that the following changes have been made to the proposed rule in accordance with subparagraph 120.54(3)(d)1., F.S., published in Vol. 43 No. 229, November 29, 2017 issue of the Florida Administrative Register.
64C-6.001 Definitions – General
(1) “Assisted Ventilation” – The use of mechanical or other devices to help maintain respiration, usually delivering air or oxygen under positive pressure. Assisted ventilation may be invasive, (i.e., oscillator, ventilator) or non-invasive, (i.e., CPAP, SiPAP, BiPAP, nCPAP).
(2) No change.
(3) “CMS RPICC-Registered Physician” – A health professional who is licensed to practice medicine or osteopathic medicine in the State of Florida. who meets the requirements of Rule 64C-4.001, Florida Administrative Code (F.A.C.), and the requirements of the CMS Provider Handbook for Physicians and Dentists.
(4) “Maternal Fetal Medicine (MFM) Physician” – A CMS RPICC-registered physician, who is board certified in Obstetrics and Gynecology (OB/GYN) and board certified in Maternal Fetal Medicine, or has passed the written MFM exam and is eligible to take the oral MFM exam for board certification, and is in the process of pursuing must demonstrate an active, continuing pursuit of board certification at the time of the CMS renewal review.
(5) No change.
(6) “Neonatologist” – A CMS RPICC-registered CMS consultant physician, as defined in Rule 64C-4.001, F.A.C., who is board certified in Neonatal-Perinatal Medicine, or is eligible to take the written Neonatal-Perinatal exam for board certification, and is in the process of pursuing must demonstrate an active, continuing pursuit of board certification at the time of the CMS renewal review.
(7) “Obstetrician” – A CMS RPICC-registered physician who is board certified in OB/GYN, or has passed the written examination of the OB/GYN board certification process, and is in the process of pursuing must demonstrate an active, continuing pursuit of board certification at the time of the CMS renewal review.
(8) “Regional Perinatal Intensive Care Center Centers (RPICC or center centers)” – A specialized unit Specialized units within a hospital hospitals specifically designed to provide a full range of health services to women with high risk pregnancies with and a full range of newborn intensive care services which has have been designated by the Department of Health, and which meets the standards as defined herein for facilities, staffing and services or commits themselves to meeting and maintaining these standards within three years of designation as a center.
(8)(9) “RPICC Data System” – A comprehensive automated information system which collects and correlates data from both components of the Regional Perinatal Intensive Care Centers Program and provides periodic analysis of RPICC Program data.
(9)(10) “RPICC Level II Neonatal Intensive Care Patient Station” – A patient care station in a RPICC with the capability of delivering special care to newborns including oxygen therapy, supplemental parenteral alimentation, constant electronic monitoring of vital signs, and with a minimum ratio of one member of the nursing staff to four patients.
(10)(11) “RPICC Level III and Level IV Neonatal Intensive Care Patient Station” – A patient care station with the capability of delivering total intensive care to newborns including total respiratory support, supplemental parenteral alimentation, constant electronic monitoring of vital signs, long term arterial catheterization, and with a minimum ratio of one member of the nursing staff to two patients, at all times, for the critical care of unstable neonates.
(11)(12) “RPICC Level IV Neonatal Intensive Care Services” – Level IV units have all the capabilities of a Level III neonatal intensive care unit and are located within institutions that can provide on-site surgical repair of serious congenital or acquired malformations (complex neonatal surgery) including support related to antenatally diagnosed congenital malformations requiring surgical repair either in utero or within the first hours of life. Level IV neonatal intensive care units have ready access to a full range of pediatric surgeons and pediatric surgical specialists and pediatric anesthesiologists to perform major surgery. Advanced imaging with interpretation on an urgent basis such as but not limited to CT, MRI, and echocardiography are available on-site 24 hours a day and 7 days a week. In addition, a full range of pediatric medical and pediatric genetic specialists are available for consultation. These support services are most frequently provided on-site in specialty children’s hospitals.
(12)(13) “RPICC Program Consultants” – A CMS RPICC-registered Neonatologist and a CMS RPICC- registered Maternal Fetal Medicine Physician that accompany the CMS Central Office RPICC staff on RPICC Center site visits.
Rulemaking Authority 120, 383.19(1)(f), (g), FS. Law Implemented 383.15, 383.16, 383.17, 383.18, 383.19 FS. History–New 9-1-81, Amended 4-25-83, Formerly 10J-7.01, Amended 6-13-87, 5-15-96, Formerly 10J-7.001, Amended_______.
64C-6.002 Standards – General.
(1) through (6) No change.
Rulemaking Authority 120, 383.19(1)(f), (g), FS. Law Implemented 383.15, 383.16, 383.17, 383.18, 383.19 FS. History–New 9-1-81, Amended 4-25-83, Formerly 10J-7.01, Amended 6-13-87, 5-15-96, Formerly 10J-7.001, Amended_______.
64C-6.003 Standards – Specific.
(1) No change.
(2) Standards for Neonatal Component – RPICC Level III Neonatal Intensive Care – The following standards pertain to the facilities, services, and population to be served under the neonatal component for RPICC Level III neonatal intensive care services.
(a). Personnel
1. Physicians
a. The director of the RPICC neonatal unit shall be a CMS RPICC-registered neonatologist.
b. Each center shall have available a CMS registered pediatric surgeon available for emergency services and telephone consultation 24 hours per day, 7 days per week.
c. Each RPICC neonatal unit shall have CMS RPICC registered neonatologists continuously available for patient care and for communication with physicians in other hospitals 24 hours per day, 7 days per week.
d. No change.
2. through 3. No change.
(b) Area and Equipment – All standards in subsection 59C-1.042(10), F.A.C., as amended 3-15-17, which is hereby incorporated by reference, are required. A copy is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX www.flrules.org. In addition, the following standards are also required.
1. through 2.No change.
(c) Patient Eligibility.
1. through 4. No change.
5. Only neonates whose attending physician is a CMS RPICC-registered neonatologist in a RPICC center are eligible for the RPICC Program. Neonates who are patients of other physicians or neonates referred to other physicians by the neonatologist, are not eligible for the RPICC Program.
(d). Services.
1. Physician Services – The patient record shall contain written comments on the patient’s treatment and condition by the CMS RPICC-registered neonatologist or a resident’s note co-signed by the CMS RPICC-registered neonatologist documenting the neonatologist’s continuing involvement in the care of the neonate.
2. through 7. No change.
(3) Standards for Neonatal Component – RPICC Level II neonatal intensive care unit – The following standards pertain to the facilities, services, and population to be served under the neonatal component for Level II neonatal intensive care services of the RPICC Program.
(a) Personnel.
1. Physicians.
a. Each Level II neonatal intensive care unit shall have 24 hour consultation and primary coverage by CMS RPICC-registered consultant neonatologists for patient care 24 hours per day, 7 days per week.
2. through 3. No change.
(b) All standards in subsection 59C-1.042(9), F.A.C., as amended 3-15-17 which is hereby incorporated by reference, are required. A copy is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX www.flrules.org. In addition, the following standards are also required:
1. through 2. No change.
(c) Patient Eligibility.
1. No change.
2. Infants served in RPICC Level II neonatal intensive care units shall be under the care of a CMS RPICC- registered consultant neonatologist, must have received CMS RPICC Program Level III or Level IV NICU care, and may require specialized nutritional support, or may require oxygen which does not exceed 40 percent at ambient pressure, or whose weight or medical or surgical diagnosis precludes discharge to recovery care.
(d) No change.
(4) Standards for RPICC Obstetrical (OB) Component – The following standards pertain to the facilities, services, and population to be served under the obstetrical component of the RPICC Program.
(a) Personnel.
1. Physicians.
a. The obstetrical service shall have 24-hour coverage by a CMS RPICC-registered obstetrician continuously available for patient care and for communication with physicians in other hospitals 24 hours per day, 7 days per week.
b. through c. No change.
2. No change.
(b) No change.
(c) Patient Eligibility.
1. through 4. No change.
a. through f. No change.
5. Only patients whose attending physician is a CMS RPICC-registered obstetrician in a center are eligible for RPICC Program funding.
6. through 7. No change.
(d) Services.
1. Physician.
a. No change.
b. Performance or insterpreation of these tests shall be made by, or under the supervision of the CMS RPICC-registered obstetrician.
2. through 5. No change.
6. Ancillary health services to include:
a. through g. No change.
h. Prenatal clases – Each center must provide for, or arrange access to, prenatal classses for patients, as recommended by the CMS RPICC-registered obstetrician.
Rulemaking Specific Authority 120, 383.19(1) FS. Law Implemented 383.15, 383.16, 383.17, 383.18, 383.19 FS. History–New 9-1-81, Amended 4-25-83, Formerly 10J-7.01, Amended 6-13-87, 5-15-96, Formerly 10J-7.001, Amended_______.
