To make modifications to the rules associated with Neonatal Transports to ensure the highest level of care for neonate patients. To make a minor modification to the equipment list regarding suction catheter sizes to ensure consistency with the ...

DEPARTMENT OF HEALTH
Division of Emergency Medical Operations

RULE NO: RULE TITLE
64J-1.001: Definitions
64J-1.006: Neonatal Interfacility Transfers
PURPOSE AND EFFECT: To make modifications to the rules associated with Neonatal Transports to ensure the highest level of care for neonate patients. To make a minor modification to the equipment list regarding suction catheter sizes to ensure consistency with the Bureau of Emergency Medical Services inspection form.
SUMMARY: The proposed rules will revise definitions regarding Neonatal Transports, eliminate the term “interfacility” so that the rule applies to all Neonate Transports, require the receiving neonatologist and the Medical Director confirm that the level of care, staffing, and equipment meet the needs of the transported neonate patient; establish criteria for Medical Directors overseeing Neonatal Transports, and require the Medical Director to confirm that team members have the required training to provide care to neonate patients.
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: 401.252(4), 401.35 FS.
LAW IMPLEMENTED: 401.252 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: Monday, August 3, 2009, 2:00 p.m. – 3:00 p.m.
PLACE: Florida Department of Health, 4025 Esplanade Way, 3rd Floor, Room 301, Tallahassee, FL 32311
A conference line will be available for those unable to attend in person. We request that parties from the same agency utilize one line if possible to allow other participants to dial in. Toll free conference number: 1(888)808-6959; Conference code: 1454440
REQUEST FOR HEARING MUST BE RECEIVED IN WRITING TO: Lisa Walker, Government Analyst II at the address below.
Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 2 days before the workshop/meeting by contacting: Alexander Macy, [phone], ext. 2735 or by email at: [e-mail]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Lisa Walker, Government Analyst II, Bureau of EMS, 4052 Bald Cypress Way, Bin C-18, Tallahassee, FL 32399, email: [e-mail] phone: [phone], ext. *2733; fax: [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

64J-1.001 Definitions.

(1) through (13) No change.

(14) Neonatal Ambulance – means an ALS permitted vehicle permitted which is designated solely for Neonatal Transport to interfacility transports of neonates to a Level II or Level III neonatal intensive care unit.

(15) Neonatal Transport – means critical care interfacility the transport of any neonate requiring emergency transfer from a hospital licensed under Chapter 395, F.S., to a facility licensed under Chapter 408, F.S., to deliver Level II or Level III neonatal intensive care services as defined in Rule 59C-1.042, F.A.C unit.

(16) Neonate – means an infant less than either 28 days of life and or less than 5 kg in weight.

Rulemaking Specific Authority 381.0011(13), 395.401, 395.4025(13), 395.405, 401.121, 401.35 FS. Law Implemented 381.0011, 395.4001, 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.404, 395.4045, 395.405, 401.121, 401.211, 401.23, 401.25, 401.35, 401.435 FS. History–New 4-26-84, Amended 3-11-85, Formerly 10D-66.485, Amended 11-2-86, 4-12-88, 8-3-88, 8-7-89, 6-6-90, 12-10-92, 11-30-93, 10-2-94, 1-26-97, Formerly 10D-66.0485, Amended 8-4-98, 7-14-99, 2-20-00, 11-3-02, 6-9-05, 10-24-05, 4-22-07, Formerly 64E-2.001, Amended 1-12-09,_______.

64J-1.006 Neonatal Interfacility Transfers.

(1) A Neonatal Ambulance Neonates requiring critical care interfacility transport to a Level II or Level III Neonatal Intensive Care Unit shall be transported in either a neonatal ambulance or a permitted ALS or BLS transport ambulance or aircraft.

(a) A neonatal ambulance shall meet the requirements listed in Table V, paragraphs 64J-1.006(1)(c) and (d) and subsections 64J-1.006(2) and (3), F.A.C., and shall be exempt from meeting the equipment and medical supplies listed in Rule 64J-1.002, Table I, F.A.C., and in Rule 64J-1.003, Table II, F.A.C.

(2)(b) For any Neonatal Transport, the receiving When a permitted BLS or ALS ambulance is used to transport a neonate, the sending neonatologist or physician and the EMS provider’s Mmedical Ddirector shall confirm ensure that the level of care, staffing, and equipment is commensurate to the needs of the Nneonate being transported.

(3)(c) The Nneonatal Aambulance as defined in subsection 64J-1.001(14), F.A.C., shall have exterior wording or marking which identifies that the ambulance is only for Nneonatal Ttransport. The wording shall be such that the public cannot mistake a neonatal vehicle as an ambulance for general patient care.

(4)(d) Any EMS provider operating a permitted Nneonatal Aambulance for transporting neonates to a Level II or Level III Neonatal Intensive Care Unit shall have a Medical Director for all Neonatal Transports who meets the requirements of 64J-1.004(1)-(4)(a)-(f), F.A.C., except as follows: contract with a neonatologist or have the hospital’s staff neonatologist assigned as the provider’s medical director.

(a) The Medical Director shall be board certified and active in Neonatal-Perinatal Medicine, and shall demonstrate and have available for review by the department documentation of active participation on a national, regional or statewide physician group involved in Neonatal Transport;

(b) The Medical Director is not required to have prehospital care experience;

(c) All references to “patients” and “BLS and ALS procedures” shall be understood as referring to “neonates” and “neonatal advanced life support procedures” respectively;

(d) All references to “paramedics” and “EMTs” shall be understood as referring to persons staffing the Neonatal Transport as referenced in subsection (5), below; and

(e) The Medical Director shall participate in direct contact time with the transport staff while transporting a neonate for a minimum of 10 hours per year.

 

TABLE V (Reference Section 64J-1.006, F.A.C.) Neonatal Interfacility Transfers
ITEM			QTY.
1. Direct two-way communications with the
designated neonatologist or attending
physician and or receiving ICU.
2. A standby or backup power source			One.
other than the one contained in
the isolette.
3. A source of electrical power			One.
sufficient to operate the isolette
and ancillary electrically powered
equipment.
4. A transport incubator with portable			One.
power supply, portable oxygen tanks
or liquid oxygen, and a source of
compressed air, including appropriate
valves, meters, and fittings.
5. Portable heart rate monitor with			One per patient.
visual or audible display and alarm
system.
6. Portable blood pressure monitor			One each.
with assortment of cuff sizes suitable
for infants.
7. Battery powered mechanical I.V. pumps			Two.
capable of delivering as low as 1 cc.
increments for I.V. fluids.
8. Battery or self-powered oxygen sensor			One.
and transcutaneous oxygen monitor or
oxygen saturation monitor.
9. Oxygen delivery device and tubing			One.
capable of administering high
concentrations of oxygen.
10. Temperature monitoring device.			One.
11. Portable ventilator appropriate			One.
for neonatal patients.
12. Anesthesia and/or self-inflating bag
with oxygen reservoir less than
750 ml and manometer (pressure gauge);
premature, newborn and infant size
clear masks.
13. Laryngoscope handle.			One.
14. Blades.			Miller 00, Miller 0.
15. Bulbs and batteries.			Two each.
16. Endotracheal tubes.			2.0, 2.5, 3.0, 3.5,
			4.0.
17. Stylet.			Two each.
18. Adapters.			Assortment of sizes.
19. Oral Airways.			Assortment of sizes.
20. Suction equipment with low suction			One.
capabilities of less than 80 mm of hg.
21. Sterile Gloves assorted sizes.			Sufficient quantity
for all crew
members.
22. Suction catheters.		Size 5.0, 6.0, 6.5, 8, & 10	Two each.
			8, & 10.
23. Syringes sizes 1 cc. through 60 cc.			Assortment of sizes.
24. Medication access device.			Two each.
25. Vascular access devices 23-27 gauge.			Assortment of sizes.
26. I.V. extension tubing.			Sufficient length to
			administer I.V.
27. Securing device.			Assorted sizes.
28. I.V. filters.			Two.
29. Umbilical catheters.		Size 3.5 & 5	Two.
30. Antiseptic solution.			Ten.
31. Blood sugar device.			One.
32. Lancets.			Five.
33. Neonatal stethoscope.			One.
34. Flashlight.			One.
35. Gauze pads.			Assortment of sizes.
36. No. 5 & No. 8 French feeding tubes.			One each.
37. High intensity light capable of			One.
transillumination.
38. Approved biomedical waste plastic			One each.
bag or impervious container and
used sharps container per Chapter
64E-16, F.A.C.
39. Gloves  latex or other suitable			Sufficient quantity
materials.			for all crew members.
40. Respiratory face masks.			Sufficient quantity
			for all crew members.
41. Special procedure tray or instruments			One.
with capability for performing
umbilical catheterization, venous
cutdown and thoracostomy.
42. Bulb syringe. (Additional to OB kit)			One.
43. Cord clamp.			One.
44. Chest tube evacuation device.			One.
45. Needle aspiration device or			Appropriate sizes
chest tubes.			for neonate.
MEDICATION		WT/VOL	QTY.
1. Atropine Sulfate.		1 mg./10 ml.	One.
2. Injectable Vitamin K.		1 mg./0.5 ml.	One.
3. Antibiotics, to be
determined by medical
director.
4. Calcium Gluconate.		10%  10- ml.	One.
5. Digoxin ped.		0.1 mg./ml.	One.
6. Anticonvulsant as
required by medical
director.
7. Dextrose.		50% 50 cc.	One.
8. Dopamine or		Depends on	One.
dobutamine.		medication
9. Epinephrine.		1:10,000	One.
10. Eye prophylaxis.			One.
11. Furosemide (Lasix).		20 mg./2 ml.	One.
12. Heparin.			One.
13. Lidocaine.		1%/2 mg.	One.
14. Naloxone (Narcan).		1.0 mg./ml or	One.
		.4 mg./ml.
15. Paralyzing agent.			One.
16. Phenobarbital.			One.
17. Prostin VR.		500 mcg/ml.	One.
(available for
transport)
18. Sodium Bicarbonate.		4.2% soln.	One.
19. Sedative as			One.
determined by the
Mmedical Ddirector.
20. Volume expander.			One.
21. I.V. fluid.		Bags of	One each.
		D5W and D10W
22. Injectable			One.
non-preservative
sterile water.
23. Injectable			One.
non-preservative normal saline.

 

(5) Each Neonatal Transport permitted ambulance or neonate ambulance when transporting a neonate to a Level II or Level III Neonatal Intensive Care Unit shall be staffed with a minimum of two persons, excluding the driver or pilot. One person shall be a Registered neonatal Nurse (RN), the second person shall be either an RN, a neonatal registered respiratory therapist (RT), or a paramedic or a registered neonatal nurse. Physicians may be substituted by the Medical Director for either of the two persons. The staffing for each Nneonatale Ttransport shall be determined by the licensee’s Mmedical Ddirector in conjunction with the attending physician and the neonatologist. A physician can be substituted for any team member. The Medical Director shall confirm that the staffing for each Neonatal Transport is capable of performing neonatal advanced life support procedures, as referenced by the American Academy of Pediatrics in Guidelines for Air and Ground Transport of Neonatal and Pediatric Patients, 3rd ed, which is incorporated by reference and available at http://www.aap.org.

(a) The Medical Director provider shall confirm assure the RN is licensed in accordance with Chapter 464, F.S.; has have a minimum of 4,000 hours RN experience, which includes 2,000 hours of Level II or Level III Neonatal Intensive Care Unit (NICU) nursing experience; has an and have American Heart Association (AHA) Neonatal Resuscitation Program (NRP) Certification or an equivalent certification; has and successfully completed a neonatal transport stabilization program within 2 years prior to application to Nneonatal Ttransport, approved in writing by a Mmedical Ddirector; and, has accompaniedy a minimum of six Nneonatal Ttransports prior to staffing a Nneonatal Ttransport as the only RN in attendance.

(b) The Medical Director provider shall confirm assure the RT is registered by the National Board of Respiratory Care with a minimum of 2,000 hours of Level II or Level III NICU experience or is be certified as a RT with a minimum of 3,000 hours of Level II or Level III NICU experience.; The Medical Director shall also confirm that the RT has:

1. An and have AHA NRP Certification or an equivalent certification;

2. and Ssuccessfully completed a neonatal transport stabilization program within 2 years prior to application to Nneonatal Ttransport, approved in writing by a Mmedical Ddirector; and

3. and, Aaccompaniedy a minimum of six Nneonatal Ttransports prior to staffing a transport as the only RT in attendance.

(c) The Medical Director provider shall confirm assure the paramedic is either a Florida-licensed paramedic with a minimum of 2,000 hours of Level II or Level III NICU Neonatal Intensive Care unit experience; or be a Florida-licensed paramedic with a minimum of 3,000 hours experience;. The Medical Director shall also confirm that the paramedic has:

1. An and have AHA NRP Certification or an equivalent certification;

2. and Successfully completed a neonatal transport stabilization program within 2 years prior to application to Nneonatal Ttransport, approved in writing by a Mmedical Ddirector; and

3. and, Accompaniedy a minimum of six Nneonatal Ttransports prior to staffing a Nneonatal Ttransport.

(d) The A neonatologist or a licensee’s Mmedical Ddirector may make medical staff substitutions with individuals of comparable skills when the condition of the neonate warrants such substitution.

(6)(3) Treatment protocols for the management of the neonate neonatal patient from the receiving responsible neonatologist shall accompany each Nneonatal Ttransport.

Rulemaking Specific Authority 381.0011, 383.19, 395.405, 401.251(6), 401.35 FS. Law Implemented 381.001, 383.15, 395.405, 401.24, 401.25, 401.251, 401.252, 401.26, 401.265, 401.27, 401.30, 401.31, 401.35, 401.41, 401.411, 401.414, 401.421 FS. History–New 11-30-93, Amended 1-26-97, Formerly 10D-66.0525, Amended 8-4-98, 9-3-00, 12-18-06, Formerly 64E-2.006, Amended________.

NAME OF PERSON ORIGINATING PROPOSED RULE: John C. Bixler, Chief, Bureau of Emergency Medical Services
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ana Viamonte Ros, State Surgeon General, Florida Department of Health
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 18, 2009
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 7, 2007 Vol/No 33/49; January 4, 2008 Vol/No 34/1; February 15, 2008 Vol/No 34/7; June 13, 2008 Vol/No 34/24; December 24, 2008 Vol/No 34/52