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IN RE: STATE OF FLORIDA BOARD OF NURSING Final Order No. DOH-21-1525-J)s -MQA FILED DATE- NOV O 3 2021 ~•rlm ,., of Heolth ··~~l~ THE PETITION FOR DECLARATORY STATEMENT OF: ALLYSONSAUBER,APRN FINAL ORDER THIS MATTER came before the Florida Board of Nursing (Board) pursuant to Section 120.565, Florida Statutes. At a duly-noticed public meeting held on October 7, 2021, in Kissimmee, Florida, the Board considered a Petition for Declaratory Statement filed by Allyson Sauber (Petitioner). The Petition was filed with the Depat1ment of Health Clerk on August 19, 2021; a copy of which is attached hereto. The Petition was duly filed and noticed in the Florida Administrative Register in Volume 47, Number 165, on August 25, 2021. On September 13, 2021, a Motion to Intervene was filed on behalf of the Florida Medical Association, Inc, Florida Society of Plastic Surgeons, Inc., Florida Society of Dermatology and Dermatologic Surgery, Inc., and Florida Osteopathic Medical Association in opposition to the filed Petition for Declaratory Statement. Petitioner was not present at the hearing. The Board was represented by Deborah Bartholow Loucks, Senior Assistant Attorney General. Christopher Nuland, Attorney at Law, appeared on behalf of the intervenors. The Board granted the Petition to Intervene and heard comments and discussion from the intervenors. The Board denied the Petition because it did not have sufficient information upon which to formulate a proper response. The intervenors dismi.ssed their Motion. THEREFORE, the Petition for Declaratory Statement is hereby denied. I
Transcript

IN RE:

STATE OF FLORIDA BOARD OF NURSING

Final Order No. DOH-21-1525-J)s -MQA

FILED DATE- NOV O 3 2021 ~•rlm ,., of Heolth

··~~l~ THE PETITION FOR DECLARATORY STATEMENT OF: ALLYSONSAUBER,APRN

FINAL ORDER

THIS MATTER came before the Florida Board of Nursing (Board) pursuant to Section

120.565, Florida Statutes. At a duly-noticed public meeting held on October 7, 2021, in

Kissimmee, Florida, the Board considered a Petition for Declaratory Statement filed by Allyson

Sauber (Petitioner). The Petition was filed with the Depat1ment of Health Clerk on August 19,

2021; a copy of which is attached hereto. The Petition was duly filed and noticed in the Florida

Administrative Register in Volume 47, Number 165, on August 25, 2021. On September 13,

2021, a Motion to Intervene was filed on behalf of the Florida Medical Association, Inc, Florida

Society of Plastic Surgeons, Inc., Florida Society of Dermatology and Dermatologic Surgery,

Inc., and Florida Osteopathic Medical Association in opposition to the filed Petition for

Declaratory Statement.

Petitioner was not present at the hearing. The Board was represented by Deborah

Bartholow Loucks, Senior Assistant Attorney General. Christopher Nuland, Attorney at Law,

appeared on behalf of the intervenors.

The Board granted the Petition to Intervene and heard comments and discussion from the

intervenors.

The Board denied the Petition because it did not have sufficient information upon which

to formulate a proper response. The intervenors dismi.ssed their Motion.

THEREFORE, the Petition for Declaratory Statement is hereby denied. I

This Order shall become effective upon filing with the Clerk of the Department of

Health.

DONE AND ORDERED this ~!!.d day of November, 2021.

BOARD OF NURSING

~ It tXCI iu,nJ w, Joe R. Baker, Jr., Executive Director for Deborah McKeen, CD-LPN, BS, Chair

CERTIFICATE OF SERVICE

I HEREBY CERTIFY that a true and correct copy of the foregoing has been provided by

U.S. Mail to: Allyson Sauber, 9385 165th Place North, Jupiter, Florida 33478 and by

electronic mail to: counsel of record for the intervenors, Christopher Noland,

[email protected]; Mary Thomas, [email protected]; and Jason Winn,

[email protected]; and to: Deborah Loucks, Senior Assistant Attorney General,

[email protected], Angela Southwell, Paralegal Specialist, Office of the

Attorney General, [email protected]; and Cassandra Fullove, Paralegal

Specialist, Office of the Attorney General, [email protected]; on

1\ ' /\}' ' 3 . 0 ---'l'---"-V-"u---=--1,; _______ , 2 21.

2

TO:

FROM:

DATE:

RE:

Janet Haiiman, Chief Bureau of HCPR

Joe Baker, Jr., Executive Director FBON

October 27, 2021

Delegation of Authority

The following manager is delegated authority for the Board office as noted:

I 0/28-29 Nicole Benson Program Ops Administrator

Thank you.

JBjr/ms

From: Sent: To:

Subject:

Baker, Joe Tuesday, November 2, 2021 5:47 AM Angela Southwell; Carney, KC; Debbie McKeen; DL MQA Board of Nursing/CNA; Hartman, Janet E; Knispel, Matthew L; Pouncey, Lola T; Wenhold, Jennifer; Gabadage, Gangul; Johnson, Helaine; Johnson, Jeffrey C; Landry, Gary P; Love, Andrew; Parsons, Victoria R; Witters, Matthew G; Perez, Chelsea K; David Flynn; Deborah Loucks; Hollingsworth, Jessica

Re: Delegation Memo -- 10/28-29

This delegation is extended to include today, 11/2. Thank you.

Sent from my FDOH iPhone

1

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To the Florida Department of Health.

Request for a "Petition for a Declaratory Statement"

FILED DEPARTMENT OF HEALTH

DEPUTY CLERK CLERK: j1. mamfa :M.oraCes DATE: AUG l 9 2021

"Petition for Declaratory Statement Before the Florida Health Department and Florida Board of Nursing"

Petitioner: Allyson Sauber APRN in Florida APRN9430583 9385 i 65th Pl. N., Jupiter, FL 33478 (4 i 9) 464-2033 [email protected] (no fax number)

No legal representative

Seeking clarification on whether

i. I, as a Family Nurse Practitioner in the state of Florida, am able to legally perform laser liposuction with subsequent autologous fat transfer procedure (with Beautifill machine, by Alma)?

a. With my only training being that provided by the Alma company (9 hours of observation of the procedure, followed by 6-8 hours of performing the procedure under the supervision of a physician)?

b. If further training is required, what would this include - would this require me to obtain an RNFA, perform a certain number of cases under direct physician supervision?

c. Am I able to perform this procedure in outpatient office setting (level i office procedure, with less than i 000cc fat removal) - without a physician directly present (and only available by phone)? (under a collaborating agreement with a plastic surgeon)

There is no documentation to state that APRNs in Florida can or cannot perform laser liposuction with autologous fat transfers. This procedure harvests the fat in a low intensity liposuction procedure (using only oral medications like Tramadol and Xanax, with tumescent localized anesthesia used). There is not general anesthesia and the patient is awake and oriented, able to physically move into different positions to assist the practitioner during the procedure.

This legal gray zone - where it is not clearly documented in either the Board of Nursing or the Health Department - is of concern to myself.

I am working at a medical spa that seeks to have this machine used by myself, an APRN. The collaborating plastic surgeon is not trained in this particular machine and will not be on site for these procedures, though available by phone contact. The procedure would require a crash cart and does involve some blood loss, though reported to be minimal enough to not require replacement IV fluids given.

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My current credentials include: my FNP licensure, with my only surgical experience working in an ENT clinic performing nasal endoscopies and ear procedures, and a class by Alma, the manufacturers of the Beautifill machine (includes 9 hours of observation of procedures, 9 hours of hands-on procedure time with supervising physician).

As liposuction is a procedure with significant potential risks to the patient, I want to confirm that this procedure could be considered within my scope of practice.

I have seen other APRNs advertising this procedure, performed by themselves in offices with and without doctors present. However, I have also talked to a lot of plastic surgeons dealing with the fall out of inexperienced practitioners trying to perform such a procedure, resulting in patient injury.

I am interested in providing my patients with the best, safest care. I am interested in gaining clarifications on the questions above - as the medical spa world in Florida is booming and as machines come out that offer non-surgeons ways to provide laser fat transfers. We need clarification in this industry.

According to Florida Board of Nursing website,

"Nurses have the option of filing a "Petition for Declaratory Statement". In many instances nursing duties and responsibilities are not specifically addressed in the Florida Nurse Practice Act (Chapter 464, FS), or the Rules of the Florida Board of Nursing (Title 64B9, Florida Administrative Codes).

I have looked within the Nurse Practice Act and the Rules of the Florida Board of Nursing - I am unable to find definitive statements that indicate that laser liposuction is within or outside of an APRN's scope of practice.

This statement from the board discusses thatAPRNs can perform functions as indicated in a collaborative agreement with a physician:

Statutory authority on protocols is Section 464.012(3), F.S. -An advanced practice registered nurse shall perform those functions authorized in this section within the framework of an established protocol which must be maintained onsite at the location or locations at which an advanced practice registered nurse practices.

This statement is unclear whether a protocol agreement between a physician and APRN is all that is needed to establish whether an APRN can perform a laser liposuction procedure.

The following documentation is from 464.0123, "Autonomous practice by an advanced practice registered nurse:"

(3) Practice Requirements, 5., (c) An advanced practice registered nurse engaging in autonomous practice under this section may not perform any surgical procedure other than a subcutaneous procedure.

4638

While I am cunently NOT autonomous, this is the only indication that I can find in legal documentation that states what APRNs may NOT do, as far as surgical procedures. Does the same guidelines apply to APRNs working alone in the office, under a collaborative agreement with a physician?

This following statement is of concern - by perforn1ing a liposuction procedure, am I purporting to have skills that are outside of my specialty as a Family Nurse Practitioner? Is the ability to perfmm liposuction only something that a physician or physician -assistant can perform?

(s) For an advanced practice registered nurse registered under s. 464.0123: 11. Advertising or holding himself or herself out as having certification in a specialty that he or she has not received.

With gratitude for your consideration,

Allyson Sauber APRN (FNP-C), MSN, RN

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September 13, 2021

Florida Board of Nursing Attention: Executive Director 4052 Bald Cypress Way, Bin C-02 Tallahassee, FL 32399-3258 [email protected]

FILED DEPARTMENT OF HEAL TH

DEPUTY CLERK

CLERK: Bv4>lBe4-- Coo.-,fe,y DATE: 9/13/2021

FLORIDA MEDICAL ASSOCIATION, INC., FLORIDA SOCIETY OF PLASTIC SURGEONS, INC., FLORIDA SOCIETY OF DERMATOLOGY AND

DERMATOLOGIC SURGERY, INC., AND FLORIDA OSTEOPATHIC MEDICAL ASSOCIATION, INC. MOTION TO INTERVENE IN FLORIDA

BOARD OF NURSING'S CONSIDERATION OF THE PETITION FOR DECLARATORY ST A TEMENT IN OPPOSITION OF PETITIONER ALLYSON

SAUBER, A.P.R.N.

The Florida Society of Plastic Surgeons, Inc. ("FSPS"), the Florida Society of

Dermatology and Dem1atologic Surgery, Inc. ("FSDDS"), the Florida Medical

Association, Inc. ("FMA"), and the Florida Osteopathic Medical Association, Inc.

("FOMA"), each by and through its undersigned counsel, hereby respectfully petition the

Florida Board of Nursing to allow each of the Petitioners to intervene in the Board of

Nursing's discussion of the above Petition in opposition to the Petitioner, pursuant to

Rule 28.106.205, Florida Administrative Code. In support of the proposed Intervenors'

motion, each of the proposed Intervenors hereby states:

1. The Florida Medical Association, Inc. is a Florida-based trade organization

comprised of over 25,000 Florida physicians, many of whom specialize in

dermatology, plastic surgery, or aesthetic medicine, part of which

practice includes the performance of liposuction with subsequent fat

transfer procedures which are the subject of this Petition. As a result,

4640

members of the FMA, as physicians, would be adversely affected if

providers not licensed either pursuant to Chapter 458 or 459 of the

Florida Statutes were allowed to practice specialized medicine without

the proper education, training, or physician supervision. Further, several

members of the FMA own, operate, and practice in medical spa settings

and supervise advanced practice registered nurses. The FMA routinely

participates in advocacy efforts on behalf of its members in matters

concerning the rights and obligations of physicians, including their

supervision responsibilities.

2. FMA's address, phone number and facsimile number are as follows:

1430 Piedmont Drive East, Tallahassee, FL 32308

(850) 224-6496

Facsimile: (850) 224-6667

Email: legal(tv,flmedical.org

3. Petitioner FMA's counsel's name, address, phone number, facsimile

number, and email are Mary Thomas, Esq., 1430 Piedmont Drive East,

Tallahassee, Florida 32308. (850) 224-6496. Facsimile (850) 224-6667.

Email: [email protected]

4. The Florida Society of Plastic Surgeons, Inc. ("FSPS") is a Florida-based

trade organization comprised of approximately 200 Florida physicians,

each of whom is board certified in Plastic Surgery. As a result, members

of the FSPS, as board-certified plastic surgeons, routinely perform

liposuction and fat transfer procedures that are the subject of this

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Petition and would be adversely affected if providers not licensed either

pursuant to Chapter 458 or 459 of the Florida Statutes were allowed to

perform such procedures. Moreover, the supervision of such cosmetic

medicine procedures is governed in large part by Section 458. 348(3)(c),

F.S., which regulates the supervision of those providing "dermatologic or

skin care services." The FSPS routinely participates in advocacy efforts

on behalf of its members in matters concerning the rights and obligations

of physicians, including their supervision responsibilities.

5. The FSPS routinely participates in advocacy efforts on behalf of its

members in matters concerning the rights and obligations of physicians,

including issues regarding the services that may be delegated to an

advanced practice registered nurse, such as those services cited in the

Petition.

6. FSPS's address, phone number and facsimile number are as follows:

6300 Sagewood Drive, H255

Park City, UT 84098

(435) 602-1326

Email: [email protected]

7. Petitioner FSPS's counsel's name, address, phone number, facsimile

number, and email are Christopher L. Nuland, Esq., 4427 Herschel Street,

Jacksonville, FL 32210. (904) 355-1555. Facsimile (904) 355-1585.

Email: [email protected].

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8. The Florida Society of Dermatology and Dermatologic Surgery, Inc.

("FSDDS") is a Florida-based trade organization comprised of

approximately 700 Florida physicians, each of whom is board certified in

Dermatology. As a result, members of the FSDDS, as board-certified

dermatologists, routinely perform liposuction and fat transfer procedures

that are the subject of this Petition and would be adversely affected if

providers not licensed either pursuant to Chapter 458 or 459 of the

Florida Statutes were allowed to perform such procedures. Moreover,

the supervision of such cosmetic medicine procedures is governed in

large part by Section 458. 348(3)(c), F.S., which regulates the supervision

of those providing "dermatologic or skin care services." The FDDSS

routinely participates in advocacy efforts on behalf of its members in

matters concerning the rights and obligations of physicians, including

their supervision responsibilities.

9. The FSDDS routinely participates in advocacy efforts on behalf of its

members in matters concerning the rights and obligations of physicians,

including issues regarding the services that may be delegated to an

advanced practice registered nurse, such as those services cited in the

Petition.

10. FSDDS's address, phone number and facsimile number are as follows:

6134 Poplar Bluff Road, Suite 101

Peachtree Comers, GA 30092

(904) 880-0023

4643

Facsimile: (305) 422-3327

Email: [email protected]

11. Petitioner FSDDS' counsel's name, address, phone number, facsimile

number, and email are Christopher L. Nuland, Esq., 4427 Herschel Street,

Jacksonville, FL 32210. (904) 355-1555. Facsimile (904) 355-1585.

Email: [email protected].

12. The Florida Osteopathic Medical Association (FOMA) is a Florida-based

professional trade organization comprised of nearly 7,500 Florida

osteopathic physicians, many of whom specialize in dermatology, plastic

surgery, or aesthetic medicine, part of which practice includes the

performance of liposuction and fat transfers. As a result, members of the

FOMA, as physicians, would be adversely affected if providers not

licensed either pursuant to Chapter 458 or 459 of the Florida Statutes

were allowed to perform such procedures. Further, several members of

the FOMA own, operate and practice in medical spa settings, such as the

one described by the Petitioner. As a result, members of FOMA, as

physicians, would be adversely affected if providers not licensed either

pursuant to Chapter 458 or 459 of the Florida Statutes were allowed to

perform liposuction and fat transfers. Moreover, the supervision of the

injection of fillers is governed in large part by Section 459. 025(3)(c), F.S.,

which regulates the supervision of those osteopathic physicians

providing "dermatologic or skin care services." FOMA routinely

participates in advocacy efforts on behalf of its membe_rs in matters

4644

concerning the rights and obligations of physicians, including supervision

issues.

13. FOMA's address, phone number and facsimile number are as follows:

2544 Blairstone Pines Drive, Tallahassee, FL 32301

(850) 878-7363

Facsimile: (850) 942-7538

Email: [email protected]

14. Petitioner FOMA legal counsel's name, address, phone number, facsimile

number, and email are Jason D. Winn, Esq., of Winn Law, 2709 Killarney

Way, Suite 4, Tallahassee FL 32309. (850) 222-7199. Facsimile (850)

222-1562. Email: [email protected].

15. A substantial number of the members of each of the Petitioners routinely

practice aesthetic medicine which includes the performance of

liposuction and fat transfers. Moreover, substantial number of the

members of each of the parties to this Motion supervise Advanced

Practice Registered Nurses performing such procedures pursuant to

Section 458.345(3)(c) and/or Section 459.023(3)(c), Florida Statutes.

Therefore, a substantial number of the members of each of the proposed

Intervenors would be substantially affected by the Board's decision in

this matter, as they have a unique and vested interest in the outcome of

the subject Petition. As a result, the substantial interests of each of the

proposed Intervenors will be affected by the proceeding, and each of the

proposed Intervenors therefore has standing to participate in these

4645

proceedings. See Florida Home Builders Association v. Department of

Labor and Employment Security, 412 So.2d 351 (Fla. 1982).

16. The Petitioner is licensed as an "Advanced Practice Registered Nurse,"

pursuant to Florida Statute Section 464.012. Section 464.012, F.S., sets

forth the scope of practice of such practitioners, to wit:

17. 464.012 Licensure of advanced practice registered nurses; fees; controlled substance prescribing.-

(1) Any nurse desiring to be licensed as an advanced practice registered nurse must apply to the department and submit proof that he or she holds a current license to practice professional nursing or holds an active multistate license to practice professional nursing pursuant to s. 464.009 5 and that he or she meets one or more of the following requirements as determined by the board:

(a) Certification by an appropriate specialty board. Such certification is required for initial state licensure and any licensure renewal as a certified nurse midwife, certified nurse practitioner, certified registered nurse anesthetist, clinical nurse specialist, or psychiatric nurse. The board may by rule provide for provisional state licensure of certified registered nurse anesthetists, clinical nurse specialists, certified nurse practitioners, psychiatric nurses, and certified nurse midwives for a period of time determined to be appropriate for preparing for and passing the national certification examination.

(b) Graduation from a program leading to a master's degree in a nursing clinical specialty area with preparation in specialized practitioner skills. For applicants graduating on or after October 1, 1998, graduation from a master's degree program is required for initial licensure as a certified nurse practitioner under paragraph (4)(a).

1. For applicants graduating on or after October 1, 2001, graduation from a master's degree program is required for initial licensure as a certified registered nurse anesthetist who may perform the acts listed in paragraph (4)(b).

2. For applicants graduating on or after October 1, 1998, graduation from a master's degree program is required for initial licensure as a certified nurse midwife who may perform the acts listed in paragraph ( 4)(c).

4646

3. For applicants graduating on or after July 1, 2007, graduation from a master's degree program is required for initial licensure as a clinical nurse specialist who may perform the acts listed in paragraph ( 4)(d).

(2) The board shall provide by rule the appropriate requirements for advanced practice registered nurses for the advanced nursing practices of certified nurse midwives, certified nurse practitioners, certified registered nurse anesthetists, clinical nurse specialists, and psychiatric nurses.

(3) An advanced practice registered nurse shall perform those functions authorized in this section within the framework of an established protocol that must be maintained on site at the location or locations at which an advanced practice registered nurse practices, unless the advanced practice registered nurse is registered and practicing under s. 464.0123. In the case of multiple supervising physicians in the same group, an advanced practice registered nurse must enter into a supervisory protocol with at least one physician within the physician group practice. A practitioner currently licensed under chapter 458, chapter 459, or chapter 466 shall maintain supervision for directing the specific course of medical treatment. Within the established framework, an advanced practice registered nurse may: (a) Prescribe, dispense, administer, or order any drug; however, an advanced practice registered nurse may prescribe or dispense a controlled substance as defined ins. 893.03 only if the advanced practice registered nurse has graduated from a program leading to a master's or doctoral degree in a clinical nursing specialty area with training in specialized practitioner skills.

(b) Initiate appropriate therapies for certain conditions.

(c) Perform additional functions as may be determined by rule in accordance withs. 464.003(2).

(d) Order diagnostic tests and physical and occupational therapy.

(e) Order any medication for administration to a patient in a facility licensed under chapter 395 or part II of chapter 400, notwithstanding any provisions in chapter 465 or chapter 893.

( 4) In addition to the general functions specified in subsection (3), an advanced practice registered nurse may perform the following acts within his or her specialty:

(a) The certified nurse practitioner may perform any or all of the following acts within the framework of established protocol:

4647

1. Manage selected medical problems. 2. Order physical and occupational therapy. 3. Initiate, monitor, or alter therapies for certain uncomplicated acute illnesses. 4. Monitor and manage patients with stable chronic diseases. 5. Establish behavioral problems and diagnosis and make treatment recommendations.

(b) The certified registered nurse anesthetist may, to the extent authorized by established protocol approved by the medical staff of the facility in which the anesthetic service is performed, perform any or all of the following:

1. Determine the health status of the patient as it relates to the risk factors and to the anesthetic management of the patient through the performance of the general functions. 2. Based on history, physical assessment, and supplemental laboratory results, determine, with the consent of the responsible physician, the appropriate type of anesthesia within the framework of the protocol. 3. Order under the protocol preanesthetic medication. 4. Perform under the protocol procedures commonly used to render the patient insensible to pain during the performance of surgical, obstetrical, therapeutic, or diagnostic clinical procedures. These procedures include ordering and administering regional, spinal, and general anesthesia; inhalation agents and techniques; intravenous agents and techniques; and techniques of hypnosis. 5. Order or perform monitoring procedures indicated as pertinent to the anesthetic health care management of the patient. 6. Support life functions during anesthesia health care, including induction and intubation procedures, the use ofappropriate mechanical supportive devices, and the management of fluid, electrolyte, and blood component balances. 7. Recognize and take appropriate corrective action for abnormal patient responses to anesthesia, adjunctive medication, or other forms of therapy. 8. Recognize and treat a cardiac arrhythmia while the patient is under anesthetic care. 9. Participate in management of the patient while in the postanesthesia recovery area, including ordering the administration of fluids and drugs. 10. Place special peripheral and central venous and arterial lines for blood sampling and monitoring as appropriate.

(c) The certified nurse midwife may, to the extent authorized by an established protocol which has been approved by the medical staff of the health care facility in which the midwifery services are performed, or

4648

approved by the nurse midwife's physician backup when the delivery is performed in a patient's home, perform any or all of the following: 1. Perform superficial minor surgical procedures. ( emphasis added) 2. Manage the patient during labor and delivery to include amniotomy, episiotomy, and repair. 3. Order, initiate, and perform appropriate anesthetic procedures. 4. Perform postpartum examination. 5. Order appropriate medications. 6. Provide family-planning services and well-woman care. 7. Manage the medical care of the normal obstetrical patient and the initial care of a newborn patient.

(d) The clinical nurse specialist may perform any or all of the following acts within the framework of established protocol:

1. Assess the health status of individuals and families using methods appropriate to the population and area of practice. 2. Diagnose human responses to actual or potential health problems. 3. Plan for health promotion, disease prevention, and therapeutic intervention in collaboration with the patient or client. 4. Implement therapeutic interventions based on the nurse specialist's area of expertise and within the scope of advanced nursing practice, including, but not limited to, direct nursing care, counseling, teaching, and collaboration with other licensed health care providers. 5. Coordinate health care as necessary and appropriate and evaluate with the patient or client the effectiveness of care. (e) A psychiatric nurse, who meets the requirements ins. 394.455(36), within the framework of an established protocol with a psychiatrist, may prescribe psychotropic controlled substances for the treatment of mental disorders.

18. It should be noted that even specially trained nurse midwives may only

perform "superficial minor surgical procedures."

19. It should also be noted that F.S. 464.0123 states that Autonomous APRNs

may not perform any surgical procedure other than a "subcutaneous

procedure."

20. Laser liposuction, like all liposuction, involves the surgical insertion of

both the laser and a cannula into the subject area and has been associated

with bowel perforations and other major complications. The risk of

4649

complications is enhanced considerably when the transfer of the

extracted fat to other parts of the body is added to the procedure, as has

repeatedly been seen with regard to such procedures as gluteal fat

transfers.

21. In 2019, the Legislature recognized the dangers of liposuction when it

created Florida Statutes 458.328 and 459.0138, which state in pertinent

part:

458.328 and 459.0138 Office surgeries.­

(1) REGISTRATION.-

(a) An office in which a physician [emphasis added] performs a liposuction procedure in which more than 1,000 cubic centimeters of supernatant fat is removed, a Level II office surgery, or a Level III office surgery must register with the department unless the office is licensed as a facility under chapter 390 or chapter 395.

22. The above statutes demonstrate that the Legislature did not even

envision the possibility of non-physicians performing such procedures.

23. Recognizing the need for added safety, the Florida Board of Medicine and

Florida Board of Osteopathic Medicine have enacted strict rules for the

performance of liposuction, especially liposuction in excess of 1,000 cc of

supernatant fat and fat transfer procedures. For instance, 64B8-

9.009(2)(d)-(f) and 64B15-14.007(2)(d)-(f) state:

(d) In any liposuction procedure, the surgeon is responsible for determining the appropriate amount of supernatant fat to be removed from a particular patient. A maximum of 4000cc supernatant fat may be removed by liposuction in the office setting. A maximum of S0mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting. (e) Liposuction may be performed in combination with another separate surgical procedure during a single Level II or Level III operation, only in the following circumstances:

4650

1. When combined with abdominoplasty, liposuction may not exceed 1000cc of supernatant fat, 2. When liposuction is associated and directly related to another procedure, the liposuction may not exceed 1000 cc of supernatant fat, 3. Major liposuction in excess of 1000cc supernatant fat may not be performed in a remote location from any other procedure.

24. Likewise, 64B8-9.009(3)(b) and 64B15-14.007(3)(b) require several

other precautions, even for Level I procedures, to wit:

(b) Standards for Level I Office Surgery.

1. Training Required. Surgeon's continuing medical education should include: proper dosages; management of toxicity or hypersensitivity to regional anesthetic drugs. One assistant must hold current certification in an American Heart Association, American Safety and Health Institute, American Red Cross, Pacific Medical Training approved Basic Life Support course with didactic and skills components, or ACLS Certification Institute Basic Life Support course with didactic and skills components, and the surgeon must hold current certification in an American Heart Association, American Safety and Health Institute, Pacific Medical Training approved Advanced Cardiac Life Support course with didactic and skills components, or ACLS Certification Institute Advanced Cardiac Life Support course with didactic and skills components.

2. Equipment and Supplies Required. Intravenous access supplies, oxygen, oral airways, and a positive pressure ventilation device shall be available in the office, along with the following medications, stored per manufacturer's recommendation: a. Atropine 3 mg, b. Diphenhydramine 50 mg, c. Epinephrine 1 mg in 10 ml, d. Epinephrine 1 mg in 1 ml vial, 3 vials total; and, e. Hydrocortisone 100 mg. f. If a benzodiazepine is administered, Flumazenil 0.5 mg in 5 ml vial, 2 vials total; and, g. If an opiate is administered, Naloxone 0.4 mg in 1 ml vial, 2 vials total.

3. When performing minor procedures such as excision of skin lesions, moles, warts, cysts, lip om as, and repair oflacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia, physicans are exempt from subparagraphs (3)(b)1. and 2., above. Current Basic Life Support certification is recommended but not required.

4651

4. Assistance of Other Personnel Required. No other assistance is required, unless the specific surgical procedure being performed requires an assistant.

25. By contrast, the Board of Nursing has no such rules in place to protect

patients who may have such procedures performed by any of its

licensees.

26. Based upon the above, the parties to this Motion aver that the intended

conduct of Petitioner is inconsistent with existing Florida law, which does

not authorize a family-practice APRN to perform such procedures, would

be dangerous to the public in that the regulatory protections imposed

upon physicians do not exist for APRNs, and the procedures

contemplated in the Petition should therefore be prohibited.

27. The authority of an agency to issue a declaratory statement is limited by

Section 120.565, F.S., to a determination "as to the applicability of a

statutory provision ... to the petitioner's particular set of circumstances."

Lennar Homes, Inc. v. Department of Business and Professional Regulation,

Division of Florida Land Sales, Condominiums and Mobile Homes, 888 So.

2d SO, 53 (Fla. 1st DCA 2004).

28. In the instant case, the Board is being asked to ascertain whether a

family-practice APRN may, without physician supervision and with only

minimal training, perform laser-assisted liposuction along with

autologous fat transfer. The Board is also asked to determine what level

and type of training would be sufficient for an APRN to perform such

procedures. In essence, the Petitioner is requesting the Board to adopt a

4652

statuto1y interpretation that would be applicable to each and every

advanced practice registered nurse in Florida to allow them to perform

such procedures, contrary to the clear intention and language of the

statutes and rules governing liposuction.

29. When an agency is called upon to issue a declaratory statement "which

would require a response of such a general and consistent nature as to

meet the definition of a rule, the agency should either decline to issue the

statement or comply with the provisions of Section 120.54 governing

rulemaking." Agency for Health Care Administration v. Wingo. 697 So.2d

1231, 1233 (Fla. 1st DCA 1997). Because the questions presented by the

Petition are overly broad, granting the Petition would constitute an

unlawful non-rule policy and should therefore be dismissed.

WHEREFORE, the FMA, FSPS, FSDDS, and FOMA, each respectfully requests that,

pursuant to Section 120.565, Florida Statutes, it be allowed to intervene in the subject

proceeding in opposition to the Petitioner and that the Board of Nursing either issue a

Declaratory Order in opposition to Petitioner or dismiss the Petition for Declaratory

Statement.

Respectfully submitted on this 13th day of September, 2021.

~ L. ~

Christopher L. Nuland, Esq.

FLORIDA BAR NO: 890332

4653

LAW OFFICES OF CHRISTOPHER L. NULAND, P.A.

Counsel for Petitioner Florida Society of Plastic Surgeons, Inc., and Florida

Society of Dermatologists and Dermatologic Surgeons, Inc.

4427 Herschel Street

Jacksonville, FL 32210

(904) 355-1555

Facsimile: (904) 355-1585

[email protected]

Certificate of Service

I hereby certify that a copy of the foregoing was served upon the

Petitioner, Allyson Sauber, by first-class mail to 9385 165th Place, N.

Jupiter, FL 33478 and by email to [email protected], to Deborah

Loucks, Office of Attorney General, The Capitol, PL-01, Tallahassee, FL

32399 and via email to [email protected], upon the

Florida Department of Health, Agency Clerk, via U.S. Mail and Courier to

4052 Bald Cypress Way, Bin A-02, Tallahassee, FL 32399, and upon the

Board of Nursing by courier and email at 4052 Bald Cypress Way, Bin C­

O2, Tallahassee, FL 32399-3258, email [email protected], on this

13th day of September, 2021.

~L-~

Christopher L. Nuland


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