03-000011RX Victor Ortiz vs. Department Of Health, Board Of Medicine Status: Closed DOAH Final Order on Monday, April 7, 2003.

Summary: Board of Medicine`s rule requiring a licensed anesthesiologist to be present during level III office surgeries if anesthesia provider is a Certified Registered Nurse Anesthetist does not constitute invalid exercise of delegated legislative authority.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

VICTOR ORTIZ, )

)

Petitioner, )

)

vs. )

) Case No. 03 - 0011RX

DEPARTMENT OF HEALTH, )

BOARD OF MEDICINE, )

)

Respondent. )

)

FINAL ORDER

This matte r was scheduled to be heard on February 21,

2003. Prior to that date, the parties filed a Pre - Hearing

Stipulation advising that there were no disputed facts and

that the case could be resolved without need for a hearing.

Pursuant to an order issued on Fe bruary 13, 2003, the case

proceeded in accordance with Section 120.57(1)(h), Florida

Statutes, and Rule 28 - 106.204(4), Florida Administrative Code,

for consideration before the Division of Administrative

Hearings, by its designated Administrative Law Judge , Barbara

J. Staros.

APPEARANCES

For Petitioner: William E. Williams, Esquire

J. Andrew Bertron, Jr., Esquire

Huey, Guilday, Tucker, Schwartz

& Williams, P.A.

Post Office Box 12500

Tallahassee, Florida 32317 - 2500

For Respondent: Edward A. Tellechea, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

STATEMENT OF THE ISSUE

Whether Rule 64B8 - 9.009(6)(b)1.a., Florida Administrative

Code, is an invalid exercise of delegated legislative

authority pursuant to Section 120.52(8), Florida Statutes.

PRELIMINARY STATEMENT

Petitioner, Victor Ortiz, filed a Petition for

Administrative Determination of the Invalidity of Rule 64B8 -

9.009, Florida Adm inistrative Code, with the Division of

Administrative Hearings on January 6, 2003, and was assigned

to the undersigned on January 8, 2003.

A Notice of Hearing was issued on January 9, 2003,

scheduling a formal hearing for February 4, 2003. On

January 27, 2003, the Respondent filed an unopposed Motion for

Continuance. The motion was granted and the hearing was

rescheduled for February 21, 2003.

On February 10, 2003, a telephonic case management

conference took place during which the parties informed the

undersigned that the parties desired to file motions for

summary final order and that the case should proceed pursuant

to Section 120.57(1)(h), Florida Statutes, and Rule 28 -

106.204(4), Florida Administrative Code.

Pursuant to the telephonic case manag ement conference,

the parties filed a joint Pre - Hearing Stipulation on

February 12, 2003. An order was issued on February 13, 2003,

canceling the February 21, 2003, hearing and setting a

schedule for filing of motions for final summary order and any

res ponses.

On February 21, 2003, the parties each filed a Motion for

Summary Final Order asserting that there were no disputed

issues of material fact.

The parties timely filed Proposed Final Orders which have

been considered in the preparation of this F inal Order.

Petitioner also filed a Response in Opposition to Respondent's

Motion for Summary Final Order on March 5, 2003.

FINDINGS OF FACT

Stipulated Facts

1. Section 458.331(1)(v), Florida Statutes, authorizes

the Board to adopt rules establishing th e standards of

practice and care for particular physician practice settings.

2. The Board is the agency that adopted Rule 64B8 - 9.009,

Florida Administrative Code, regarding standards of care for

office surgery.

3. Petitioner, Victor Ortiz, is a Certifie d Registered

Nurse Anesthetist (CRNA), and is licensed by the Board of

Nursing pursuant to Chapter 464, Florida Statutes.

4. Mr. Ortiz is not a member of the Florida Association

of Nurse Anesthetists or the Florida Nurses Association.

5. Mr. Ortiz provid es anesthesia care to patients in

various settings under the supervision of physicians licensed

pursuant to Chapters 458 and 459, Florida Statutes. Among

other functions, Mr. Ortiz orders preanesthetic medications;

administers regional, spinal, and genera l anesthesia under

protocol and the supervision of a physician; provides life

support functions; and monitors patient condition during

surgery and in the recovery room.

6. Prior to April 15, 2002, the effective date of Rule

64B8 - 9.009(6)(b)1.a., Florida A dministrative Code (the Rule),

Mr. Ortiz administered anesthesia under the supervision of

operating physicians for all types of office surgeries,

including surgical procedures classified by the Board of

Medicine as "level III." Mr. Ortiz provided anesthes ia

services to patients in level III office surgeries under the

supervision of M.D. or D.O. operating physicians four or five

days per week on average.

7. The Rule requires that if the anesthesia provider is

a CRNA, there must be a licensed M.D. or D.O.

a nesthesiologist, other than the surgeon, to provide direct

supervision of the administration and maintenance of the

anesthesia in level III office surgeries.

8. Since the adoption of the Rule, the physicians for

whom Mr. Ortiz previously provided anesthes ia services will no

longer employ him for level III office surgeries because they

believe that it is unnecessary and cost - prohibitive to pay Mr.

Ortiz to provide the actual anesthesia services and an

anesthesiologist to directly supervise him. Consequentl y, Mr.

Ortiz' revenues have been reduced and his office practice has

been substantially and adversely affected.

CONCLUSIONS OF LAW

9. The Division of Administrative Hearings has

jurisdiction over the parties and subject matter of this

proceeding pursuan t to Section 120.56(1) and (3), Florida

Statutes.

Standing

10. The Board argues that Petitioner lacks standing

because the facts in this case do not show that the rule

directly regulates the professional conduct of CRNAs or that

it has a direct effect on his right to earn a living. The

Board also asserts that if the alleged injury is economic, the

impact of the rule must be devastating or otherwise equally

detrimental to legitimate business interests.

11. These arguments were squarely addressed by the Fi rst

District Court of Appeal in Florida Board of Medicine v.

Florida Academy of Cosmetic Surgery, Inc ., 808 So. 2d 243, at

251 (Fla. 1st DCA 2002):

The fact that the proposed rule would not

directly regulate CRNA's is not fatal to a

finding of standing. A challenger to a

rule may be 'substantially affected' by a

rule, and thus have standing to challenge

it, even where the rule or promulgating

statute does not regulate the challenger's

profession per se. Ward v. Bd. Of Trs. Of

Internal Improvement Trust Fund , 651 So.2d

1236,1238 (Fla. 4th DCA 1995). For

instance, we have held that a challenger

can be substantially affected by a rule

which has a collateral financial impact on

the challenger's business. See Televisual

Communications, Inc. v. State Dep't o f

Labor & Employment Sec. , 667 So. 2d 372

(Fla. 1st DCA 1995) . . . . Here, a

number of physicians testified that they

would not employ CRNA's in level III office

surgeries if the presence of an

anesthesiologist was required because it

would be unnece ssary and cost - prohibitive

to pay two anesthesia providers to perform

a single surgery. Although the Board and

FSA argue that the proposed rule would not

completely eliminate the opportunity for

CRNA's to participate in office surgeries

because it does no t apply to level I and

level II office surgeries, this merely goes

to the scope of the injury, and not to

whether it is real and sufficiently

immediate.

12. Petitioner has proven that he has standing to

challenge the Rule which is the subject of this dis pute. The

parties stipulated that since the adoption of the challenged

rule, the physicians for whom he previously provided

anesthesia services four or five days a week will no longer

employ him for level III office surgeries because they believe

that it is unnecessary and cost - prohibitive to pay him to

provide the actual anesthesia services and an anesthesiologist

to directly supervise him. Consequently, Petitioner's

revenues have been reduced and his office practice has been

substantially and adversely affected. Petitioner is a person

substantially affected by the Rule and entitled to bring a

Rule challenge pursuant to Section 120.56(1) and (3), Florida

Statutes.

Rule Challenge Analysis

13. The party attacking an existing agency rule has the

burden to prove that the rule constitutes an invalid exercise

of delegated legislative authority. Cortes v. State Board of

Regents , 655 So. 2d 132 (Fla. 1st DCA 1995). The challenger's

burden is a stringent one. Id. ; Charity v. Florida State

University , 680 So . 2d 463 (Fla. 1st DCA 1996).

14. The Petition for Administrative Determination of the

Invalidity of Rule 64B8 - 9.009, Florida Administrative Code,

alleges that the Rule is an invalid exercise of delegated

legislative authority within the context of Sectio n

120.52(8)(b) and (c), in that it exceeds Respondent's

rulemaking authority, and modifies or contravenes the specific

provisions of law implemented. 1/

Section 120.52(8)(b) and (c), Florida Statutes

15. Section 120.52(8), Florida Statutes, reads in

p ertinent part as follows:

(8) 'Invalid exercise of delegated

legislative authority' means action which

goes beyond the powers, functions, and

duties delegated by the Legislature. A

proposed or existing rule is an invalid

exercise of delegated legislative authority

if any one of the following applies:

* * *

(b) The agency has exceeded its grant of

rulemaking authority, citation to which is

required by s. 120.54(3)(a)1.;

(c) The rule enlarges, modifies, or

contravenes the specific prov isions of law

implemented, citation to which is required

by s. 120.54(3)(a)1.;

16. Petitioner asserts that Rule 64B8 - 9.009, Florida

Administrative Code, exceeds its grant of rulemaking authority

in violation of Section 120.52(8)(b), Florida Statutes,

be cause Section 458.303(2), Florida Statutes, strictly limits

the Board's grant of rulemaking authority in Section 458.311,

Florida Statutes. Petitioner also asserts that the rule

modifies or contravenes Section 458.303, Florida Statutes, in

violation of Se ction 120.52(8)(c), Florida Statutes, in that

it requires supervision by a licensed anesthesiologist as

opposed to any licensed physician.

17. "The authority to adopt an administrative rule must

be based on an explicit power or duty identified in the

enabling statute . . . [T]he authority for an administrative

rule is not a matter of degree. The question is whether the

statute contains a specific grant of legislative authority for

the rule, not whether the grant of authority is specific

enough ." (Emphasis in original) Florida Board of Medicine,

supra at 253, quoting Southwest Florida Water Management

District v. Save the Manatee Club, Inc. , 773 So. 2d 594, 599

(Fla. 1st DCA 2000).

18. In this instance, the Board's grant of rulemaking

authori ty is found in Section 458.331(1)(v), Florida Statutes,

which reads in pertinent part as follows:

458.331 Grounds for disciplinary action;

action by the board and department. --

(1) The following acts constitute grounds

for denial of a license or dis ciplinary

action, as specified in s. 456.072(2):

* * *

v) Practicing or offering to practice

beyond the scope permitted by law or

accepting and performing professional

responsibilities which the licensee knows

or has reason to know that he or she is no t

competent to perform. The board may

establish by rule standards of practice and

standards of care for particular practice

settings, including, but not limited to ,

education and training, equipment and

supplies, medications including

anesthetics, assista nce of and delegation

to other personnel , transfer agreements,

sterilization, records, performance of

complex or multiple procedures, informed

consent, and policy and procedure manuals.

(emphasis supplied)

19. Section 458.331(1)(v), Florida Statutes, gi ves the

Board broad rulemaking authority regarding the establishment

of standards of practice and standards of care for particular

practice settings. Specifically, it grants authority to the

Board to establish standards of practice and standards of care

r egarding medications including anesthetics and the assistance

of and delegation to other personnel.

20. This provision of Rule 64B8 - 9.009 was challenged and

upheld on different but related grounds in Florida Board of

Medicine , supra . In its analysis of the Board's rulemaking

authority, the court noted:

Section 458.331(1)(v) clearly gives broad,

unqualified, rulemaking authority to the

Board to establish 'standards of practice

and standards of care for particular

practice settings.' It does not specify

what those standards should be, or how they

should be established, leaving such matters

to the discretion of the Board. It seems

to us relatively clear that level III

office surgery is a 'practice setting' . .

. .

808 So. 2d 243 at 254.

21. Petitioner argues that the rulemaking authority

found in Section 458.331(1)(v) is strictly limited by the

language of another statute, Section 458.303, Florida

Statutes, which reads in pertinent part:

458.303 Provisions not applicable to other

practitioners; excepti ons, etc. --

(1) The provisions of ss. 458.301,

458.303, 458.305, 458.307, 458.309,

458.311, 458.313, 458.315, 458.317,

458.319, 458.321, 458.327, 458.329,

458.331 , 458.337, 458.339, 458.341,

458.343, 458.345, and 458.347 shall have no

application to:

(a) Other duly licensed health care

practitioners acting within their scope of

practice authorized by statute .

* * *

(2) Nothing in s. 458.301, s. 458.303, s.

458.305, s. 458.307, s. 458.309, s.

458.311, s. 458.313, s. 458.319, s.

458.321, s. 458.327, s. 458.329, s.

458.331 , s. 458.337, s. 458.339, s.

458.341, s. 458.343, s. 458.345, or s.

458.347 shall be construed to prohibit any

service rendered by a registered nurse or a

licensed practical nurse, if such service

is rendered under the direct supervi sion

and control of a licensed physician who

provides specific direction for any service

to be performed and gives final approval to

all services performed . Further, nothing in

this or any other chapter shall be

construed to prohibit any service rendered

b y a medical assistant in accordance with

the provisions of s. 458.3485.

(emphasis supplied)

22. Further, Petitioner argues that Section 464.012,

Florida Statutes, defines the scope of practice for certified

registered nurse anesthetists and that Rule 6 4B8 - 9.009

improperly limits the scope of practice for CRNAs. Petitioner

argues that under the language of Section 464.012, CRNAs are

free to practice under the supervision of any licensed

physician regardless of a physician's specialty or area of

practice . Section 464.012, Florida Statutes, reads in

pertinent part as follows:

(3) An advanced registered nurse

practitioner shall perform those functions

authorized in this section within the

framework of an established protocol. A

practitioner currently lic ensed under

chapter 458 , chapter 459, or chapter 466

shall maintain supervision for directing

the specific course of medical treatment .

. . .

* * *

(4) In addition to the general functions

specified in subsection (3), an advanced

registered nurse pract itioner may perform

the following acts within his or her

specialty:

(a) 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 per formed , 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, physic al 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 u nder 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 of

appropriate 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 whil e 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.

23. Section 464.003(3), Florida Stat utes, reads in

pertinent part as follows:

(3)(c) 'Advanced or specialized nursing

practice' means, in addition to the

practice of professional nursing, the

performance of advanced - level nursing acts

approved by the board which, by virtue of

postbasic spe cialized education, training,

and experience, are proper to be performed

by an advanced registered nurse

practitioner. Within the context of

advanced or specialized nursing practice,

the advanced registered nurse practitioner

may perform acts of nursing di agnosis and

nursing treatment of alterations of the

health status. The advanced registered

nurse practitioner may also perform acts of

medical diagnosis and treatment,

prescription, and operation which are

identified and approved by a joint

committee comp osed of three members

appointed by the Board of Nursing, two of

whom shall be advanced registered nurse

practitioners; three members appointed by

the Board of Medicine, two of whom shall

have had work experience with advanced

registered nurse practitioners ; and the

secretary of the department or the

secretary's designee. Each committee member

appointed by a board shall be appointed to

a term of 4 years unless a shorter term is

required to establish or maintain staggered

terms. The Board of Nursing shall ad opt

rules authorizing the performance of any

such acts approved by the joint committee.

Unless otherwise specified by the joint

committee, such acts shall be performed

under the general supervision of a

practitioner licensed under chapter 458 ,

chapter 459, or chapter 466 within the

framework of standing protocols which

identify the medical acts to be performed

and the conditions for their performance .

The department may, by rule, require that a

copy of the protocol be filed with the

department along with the notice required

by s. 458.348. (emphasis supplied)

24. Petitioner's arguments are unpersuasive. Inherent

in the medical and nursing statutes examined herein is the

recognition of a hierarchy in medicine. That is, even the

nurses who obtain certif ication to become a CRNA perform their

duties subject to medical supervision and established medical

protocol. In delineating the various functions to be

performed by a CRNA, Section 464.012(4), Florida Statutes,

uses the term "may . . . perform" which de notes a permissive

term. Brooks v. Anastasia Mosquito Control District , 148 So.

2d 64 (Fla. 1st DCA 1963). Moreover, nothing in the statutes

cited by Petitioner grants a CRNA the right to perform

services in a particular practice setting such as a level III

office setting in the manner preferred by the CRNA. The court

in Board of Medicine , supra , recognized level III office

surgery as a "practice setting" as described in Rule 64B8 -

9.009, Florida Administrative Code. The court determined that

the rule wa s within the authority specified in Section

458.331(1)(v), Florida Statutes, which gives the Board "broad,

unqualified, rulemaking authority" regarding standards of care

for particular practice settings. Id ., at 254. The court's

decision by extension con trols the practice of CRNAs under the

supervision of the physician specialist identified in Rule

64B8 - 9.009. That specialty is anesthesiology, not surgery.

Accordingly, the Board has not exceeded its grant of

rulemaking authority in enacting the provisio ns of Rule 64B8 -

9.009, Florida Administrative Code, relating to level III

office surgery as it pertains to the rights and opportunities

of CRNAs in their practice.

25. Petitioner's argument that Rule 64B8 -

9.009(6)(b)1.a., violates Section 120.52(8)(c), Florida

Statutes, in that it modifies or contravenes Section 458.303

by specifying that supervision must be by an anesthesiologist

physician and not the surgeon is equally unpersuasive for the

reasons enumerated herein. 2/

26. The language of Rule 64B8 - 9.0 09, Florida

Administrative Code, does not modify or contravene the

specific laws implemented as contemplated by Section

120.52(8)(c), Florida Statutes.

ORDER

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is

ORDERED:

The Petition f or Administrative Determination of the

Invalidity of Rule 64B8 - 9.009, Florida Administrative Code, is

denied.

DONE AND ORDERED this 7th day of April, 2003, in

Tallahassee, Leon County, Florida.

___________________________________

BARBARA J. STAROS

Admi nistrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675 SUNCOM 278 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of the

Division of Ad ministrative Hearings

this 7th day of April, 2003.

ENDNOTES

1/ Section 120.52(8)(c), Florida Statutes, creates an

opportunity to challenge a rule by alleging that it enlarges,

modifies, or contravenes the specific provisions of law

implemented, citatio n to which is required by Section

120.54(a)1., Florida Statutes. The specific provisions of law

implemented are Sections 458.331(1)(g),(t),(w) and 458.351,

Florida Statutes. The cited subsections of Section 458.331

deal with various grounds for disciplin ary action. Section

458.351 deals with reporting requirements of adverse incidents

regarding physicians or other licensee under chapter 458,

Florida Statutes. Petitioner's challenge is not based on the

specific provisions of law implemented but on Sectio n 458.303,

Florida Statutes.

2/ The court noted that the same provision of the rule in its

proposed form "has no effect whatsoever on the ability of

CRNA's to administer anesthesia in hospitals, ambulatory

surgical centers, and level I and II office surg eries." Id. ,

at 261.

COPIES FURNISHED :

William E. Williams, Esquire

J. Andrew Bertron, Jr., Esquire

Huey, Guilday, Tucker, Swartz & Williams, P.A.

Post Office Box 12500

Tallahassee, Florida 32317 - 2500

Edward A. Tellechea, Esquire

Office of the A ttorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

M. Catherine Lannon, Esquire

Lee Ann Gustafson, Esquire

Office of the Attorney General

The Capitol, Plaza Level 01

Tallahassee, Florida 32399 - 1050

Carroll Webb, Executive D irector

Joint Administrative Procedures Committee

120 Holland Building

Tallahassee, Florida 32399 - 1300

NOTICE OF RIGHT TO JUDICIAL REVIEW

A party who is adversely affected by this Final Order is

entitled to judicial review pursuant to Sectio n 120.68,

Florida Statutes. Review proceedings are governed by the

Florida Rules of Appellate Procedure. Such proceedings are

commenced by filing the original notice of appeal with the

Clerk of the Division of Administrative Hearings and a copy,

accompan ied by filing fees prescribed by law, with the

District Court of Appeal, First District, or with the District

Court of Appeal in the Appellate District where the party

resides. The notice of appeal must be filed within 30 days of

rendition of the order to be reviewed.