17-002565PL Department Of Health, Board Of Medicine vs. Myrdalis Diaz-Ramirez, M.D. Status: Closed Recommended Order on Friday, November 17, 2017.

Summary: DOH proved physician used local numbing agent on the wrong side before correcting her mistake and proceeding with local numbing and then trochanter bursa sac steriod injection on the correct side. RO: no violation of 456.072(1)(bb).

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF

MEDICINE,

Petitioner,

vs. Case No. 17 - 2565PL

MYRDALIS DIAZ - RAMIREZ, M.D.,

Respondent.

_______________________________/

RECOMMENDED ORDER

The fina l hearing was held in this case on August 24 and 25 ,

2017. It was conducted using video teleconferencing between

Sarasota and Tallahassee. Administrative Law Judge J. Lawrence

Johnston conducted the hearing.

APPEARANCES

For Petitioner: Christopher R. Di erlam, Esquire

Natalia Thomas, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way , Bin C 65

Tallahassee, Florida 32399

For Respondent: Jon M. P ellett, Esquire

The Doctors Company

Suite 401

12724 Gran Bay Parkway West

Jacksonville, Florida 32258

STATEMENT OF THE ISSUE S

The issues are whether the Respondent, a licensed physician,

violated section 456.072(1)(bb), Florida Statutes (2013 ) , 1/ by

mistakenly injecting a one - percent solution of Xylocaine® into an

unintended site on a patientÓs left hip in advance of performing

a right - side trochanteric bursa steroid injection ; and, if so ,

the appropriate penalty.

PRELIMINARY STATEMENT

After the Petitioner filed a Second Amended Administrative

Complaint against the Respondent in DOH case 2013 - 15828, charging

the section 456.072(1)(bb) violation, the Respondent disputed the

charges and requ ested a disputed fact hearing. The matter was

referred to the Division of Administrative Heari ngs (DOAH) for

assignment of an Administrative Law Judge on May 1, 2017.

After one continuance, the hearing was held on August 24

and 25 . Several documents w ere officially recognized (including

parts of the official records of other DOAH cases, and provisions

of the relevant Florida Statutes and Florida Administrative

Code), and a number of facts were stipul ated in the partiesÓ

Joint Pre - h earing Stipulation. Joint Exhibit 1 and 2 were

received in evidence. The Petitioner called Kevin Chaitoff,

M.D., to testify as an expert, and the PetitionerÓs

Exhibits 5, 7, and 8 were received in evidence. The Respondent

testified, and called the patient, L.S., and two ex perts,

Drs. Jean - Louis Horn and Albert Wu, to testify. The RespondentÓs

Exhibits A, C through H, L, M, O, and P were received in

evidence. Objections to the RespondentÓs Exhibits I, J, and K

were sustained, and those exhibits were proffered only and not

received in evidence.

The Transcript of the hearing was filed on October 12. On

October 23, the parties filed proposed recommended orders, and

the Respondent filed a closing argument. The post - hearing

submittals have been considered.

FINDING S OF FACT

1. The Petitioner is the state agency charged with

regulating the practice of medicine in Florida under section

20.43 and chapters 456 and 458, Florida Statutes (2017) .

2. The Respondent is a board - certified anesthesiologist but

no longer practices in that specialty , but instead practices pain

management medicine in Sarasota. She has been licensed as a

physician in Florida since August 15, 2006, and has not been

disciplined by any state licensing board.

3. L.S. is one of the RespondentÓs pain manage ment

patients. In August 2013, she was 50 years old, stood 5Ó8Ñ tall

and weighed 310 pounds. She was considered morbidly obese and

suffered from multiple medical issues, including recurring

trochanter bursa pain in her right hip. The Respondent proposed

a procedure involving the injection of steroidal fluid into the

right trochanter bursa sac, guided by fluoroscopy, to reduce

inflammation and alleviate the patientÓs pain. During this

procedure, contrast dye is first injected into the site to enable

the physician to use fluoroscopy to visualize and guide the

placement of the relatively large - gaged needle into the bursa sac

within the hip joint and injection of steroidal fluid into the

bursa sac.

4. The patient agreed to the proposed procedure but did n ot

want to be awake while it was being performed. It was agreed and

arranged that, instead of being performed at the RespondentÓs

office, as it normally would have been done, the procedure would

be done at the Intercoastal Medical Group Ambulatory Surgery

Center under deep sedation administered by IntercoastalÓs staff

(not by the Respondent). It also was decided and planned that

the Respondent would administer a local numbing agent , using a

smaller syringe and needle , to reduce post - operative pain from

th e bursa injection. When used for this purpose, particularly

when the patient is going to be sedated for the procedure, the

numbing agent can be administered either before or after the

bursa injection. In this case, because the patient had a great

fear of injections, it was decided to administer the numbing

agent before the bursa injection.

5. The procedure was scheduled for August 16, 20 1 3. That

morning, the patient met the Respondent in the pre - operative

holding area at Intercoastal. The patientÓs s ystems and medical

history were reviewed again, and she consented to the right

trochanter bursa steroid injection and the anesthesia. An

identification band was affixed to the patient, and the injection

site was identified and marked by the Respondent. I ntravenous

(IV) saline was started and oxygen was provided by nasal cannula.

Pre - bursa injection medications of Robinul and Versed were given

through the IV as a push. The Intercoastal anesthesiologist

evaluated the patient and pronounced her capable of safely

undergoing the injection under monitored anesthesia care. The

patient was then transported to the operating room on a

stretcher.

6. T he operating team includ ed the Respondent , a certified

registered nurse anesthetist (CRNA) who would administer the

anesthesia under the supervision of the anesthesiologist, a

circulating nurse, and a radiology technician. All but the

Respondent were on staff at Intercoastal. Anesthesia monitors

were placed, and the patientÓs identity, injection site, and

consents were confirmed. An anesthesia safety check was

completed, and the patient was assessed for a difficult airway or

aspiration risk. The team reviewed the plan and determined they

were ready to proceed. The patient rolled onto the operating

table from the stretcher, so that she was in a prone (face - down)

position. The Respondent was positioned to the patientÓs right

side, where the equipment needed for the bursa injection was

located. The patientÓs identity, consents, and injection site

were re - verified. A Ðtime - outÑ was performed before proceeding

with the administration of propofol. See Fla. Admin. Code

R. 64B8 - 9.007(2)(b). The team verbally re - confirmed the

patientÓs identity, the intended procedure, and the injection

site.

7. After the Ðtime - ou t,Ñ the CRNA administered the

propofol. In very short order, it was noted that the patientÓs

oxygen saturation had decreased, and she was having difficulty

breathing. Immediate action was taken to resuscitate the

patient. The propofol was discontinued, the stretcher was

repositioned next to the operating table, the patient was rolled

back over onto the stretcher in a supine (face - up) position, and

oxygen was given. After a short time, the patientÓs breathing

and oxygen saturation returned to normal. Th e Respondent

explained to the patient what had happened, and it was decided by

all, including the patient, to proceed. The team preferred to

use the operating table because it would be easier to use the

fluoroscope there than on the stretcher. However, b ecause of the

apneic event that resulted shortly after the patient was rolled

onto the operating table into a prone position the first time,

the team decided not to repeat that maneuver. Instead, the team

attempted to slide the patient back onto the opera ting table

while remaining in a supine position. Due to the still partially

sedated patientÓs weight, the team decided it would be too

difficult and unsafe to try to slide her onto the operating

table. Ultimately, the team decided to leave the patient on the

stretcher in a supine position.

8. With the patient still on the stretcher in a supine

position, the Respondent cleaned an unintended site on the

patientÓs left hip, which was then facing her and the injection

equipment, draped the unintended site, and began to inject it

s ubcutaneously with Xylocaine® one - percent solution as a local

numbing agent. Before more than 0.5 of the 5 mill il iters of the

intended dose in the syringe was injected, the Respondent

realized her mistake and withdrew the needle. She told the

patient w hat happened and asked if the patient wanted her to

proceed with the intended right trochanter bursa injection. The

patient said yes, and the Respondent moved to the intended right

side, injected

5 mill il iters of the numbing agent at the intended site, and

proceeded with the intended bursa injection.

9. The Respondent documented the procedure accurately.

Notwithstanding what happened, the patient still thinks very

highly of the Respondent, continues to be the RespondentÓs

patien t, and does not want the Respondent to suffer any license

discipline as a result. She does, however, want it noted in her

patient records for future reference that she overreacts to

propofol and that care should be taken not to overdose her if it

ever is used on her again.

10. No license discipline against any of the Intercoastal

staff has resulted from this incident. However, both the

Respondent and Intercoastal have changed their operative

procedures to require a second Ðtime - outÑ if an emergency

int ervenes and interrupts an ongoing procedure, as happened in

this case. This is the kind of safe practice improvements that

can come from Ðnear missesÑ and Ðclose calls.Ñ

11. The PetitionerÓs expert witness, Dr. Kevin Chaitoff,

testified that the incide nt resulted in a violation of section

456.072(1)(bb). The Respondent called two experts, Dr. Jean -

Louis Horn and Albert Wu, who testified that it did not.

12. The Respondent and her experts contend that a

trochanter bursa injection is not a surgery or the kind of

procedure that must be reported if done, or attempted, on the

wrong side or site. They also contend that the RespondentÓs

injection of some numbing agent at the wrong side or site in this

case was not a wrong side/site procedure, or attempted procedure,

because all other preparation was done for the procedure planned

for and ultimately done on the intended right hip. In their

view, what happened in this case should be chalked up as a Ðclose

callÑ or Ðnear missÑ that does not have to be reporte d, and

should not result in discipline, because it would have a chilling

effect, discourage reporting, and hinder safety improvements.

13. The testimony of the Respondent and her experts also

was based , in part , on their position that the subcutaneous

i njection of numbing agent was not preparation of the patient ,

but was something they called Ðpre - preparation.Ñ Their testimony

seems to beg the question, if that were just Ðpre - preparation,Ñ

what would qualify as preparation? Their testimony did not

answ er th is question , but it does not have to be answered to

resolve this case .

CONCLUSIONS OF LAW

14 . Because the Petitioner seeks to impose license

discipline, the Petitioner has the burden to prove its

allegations by clear and convincing evidence. See D epÓt of

Banking & Fin. v. Osborne Stern & Co., Inc. , 670 So. 2d 932 (Fla.

1996); Ferris v. Turlington , 510 So. 2d 292 (Fla. 1987). This

Ðentails both a qualitative and quantitative standard. The

evidence must be credible; the memories of the witnesses mu st be

clear and without confusion; and the sum total of the evidence

must be of s ufficient weight to convince the trier of fact

without hesitancy.Ñ In re Davey , 645 So. 2d 398, 404 (Fla.

1994). See also Slomowitz v. Walker , 429 So. 2d 797, 800

(Fla. 4th DCA 1983). ÐAlthough this standard of proof may be met

where the evidence is in conflict, . . . it seems to preclude

evidence that is ambiguous.Ñ Westinghouse Elec . Corp. v. Shuler

Bros. , Inc. , 590 So. 2d 986, 988 (Fla. 1st DCA 1991) (citations

omitted ).

15 . Disciplinary statutes and rules Ðmust be construed

strictly, in favor of the one against whom the penalty would be

imposed.Ñ Mun ch v. DepÓt of ProfÓl Reg. , Div. of Real Estate ,

592 So. 2d 1136, 1143 (Fla. 1st DCA 1992) . S ee Camejo v. DepÓt

of Bus . & ProfÓl Re g. , 812 So. 2d 583, 583 - 84 (Fla. 3d DCA 2002);

McClung v. Crim. Just. Stds. & Training CommÓn , 458 So. 2d 887,

888 (Fla. 5th DCA 1984) (Ð[W]here a statute provides for

revocation of a license the grounds must be strictly construed

because the s tatute is penal in nature. No conduct is to be

regarded as included within a penal statute that is not

reasonably proscribed by it; if there are any ambiguities

included, they must be construed in favor of the licensee.Ñ

(citing State v. Pattishall , 126 So. 147 (Fla. 1930)).

16 . The grounds proven in support of license discipline

must be tho se specifically alleged in the administrative

c omplaint. See , e.g. , Trevisani v. DepÓt of Health , 908 So. 2d

1108 (Fla. 1st DCA 2005); Cottrill v. DepÓt of Ins. , 685 So. 2d

1371 (Fla. 1st DCA 1996); Kinney v. DepÓt of State , 501 So. 2d

129 (Fla. 5th DCA 1987); Hunter v. DepÓt of ProfÓl Reg . ,

458 So. 2d 842 (Fla. 2d DCA 1984). Due process prohibits the

Petitioner from taking disciplinary action against a licensee

bas ed on matters not specifically alleged in the charging

instrument, unless those matters have been tried by consent.

See Shore Vill. Prop. OwnersÓ AssÓn, Inc. v. DepÓt of Envtl.

Prot. , 824 So. 2d 208, 210 (Fla. 4th DCA 2002); Delk v. DepÓt of

ProfÓl Reg . , 595 So. 2d 966, 967 (Fla. 5th DCA 1992).

17 . T he Second Administrative Complaint in this case

alleges that the Respondent subjected herself to license

discipline by violating section 456.072(1)(bb) by Ð[p] erforming

or attempting to perform health care se rvices on the wrong

patient, a wrong - site procedure, a wrong procedure, or an

unauthorized procedure or a procedure that is medically

unnecessary or otherwise unrelated to the patientÓs diagnosis or

medical condition. Ñ The statute continues: Ð For the pur poses of

this paragraph, performing or attempting to perform health care

services includes the preparation of the patient. Ñ

18. Construing the statute in the light most favorable to

the Respondent, as required by case law, it prohibits:

p erforming or a ttempting to perform health car e services on the

wrong patient; p erforming or attempting to perform a wrong - site

procedure; p erforming or attempting to perform a wrong procedure;

or p erforming or attempting to perform an unauthorized procedure

or a procedu re that is medically unnecessary or otherwise

unrelated to the patientÓs diagnosis or medical condition. Ñ

19. Obviously, the Respondent injected numbing agent on the

wrong site (side), where it was not authorized or medically

necessary or related to th e patientÓs diagnosis or medical

condition. However, she did not inject the wrong patient. In

addition, again construing the statute in the RespondentÓs favor,

injecting the numbing agent subcutaneously was not a procedure,

or an attempted procedure. Th e procedure was the bursa

injection, which was only attempted (and performed) on the

intended right side. This was a Ðclose call,Ñ not a section

456.072(1)(bb) violation. It was not required to be reported as

an adverse incident under either section 395. 0197(5) or section

458.351, Florida Statutes, which address surgical procedures.

See also Fla. Admin. Code R. 64B8 - 9.001(1)(a) (Mar. 9, 2000).

Similarly, rule 64B8 - 9.007(2)(a) (Jan. 29, 2013) required a

Ðtime - outÑ or ÐpauseÑ to help prevent wrong patient /wrong

side/wrong site surgeries and certain other procedures, but did

not require one for minor surgeries/procedures, such as a

trochanter bursa injection, not requiring the administrati on of

anesthesia or an anesthetic agent.

20. The Petitioner cites to Department of Health v. Robert

Burns, M.D. , DOAH Case 10 - 7289PL ( Fla. DOAH Dec. 29, 2010; Fla.

DOAH Feb . 16, 2011) , in support of its argument that the

Respondent violated section 456.072(1)(bb). However, the facts

of that case were significantly diffe rent. There, an

anesthesiologist intended to perform a particular procedure --

namely, a dorsal medial nerve block on the right side at the

cervical level of the spine C5/C6/C7 -- but instead performed the

procedure on the wrong (left) side. The Burns case w ould have

applied had the Respondent performed a trochanter bursa sac

steroid injection on the left side, which did not happen.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is RECOMMENDED that the Board of Medicine ente r a final

finding the Respondent not guilty of violating section

456.072(1)(bb) and dismissing the Second Amended Administrative

Complaint.

DONE AND ENTERED this 17 th day of November , 2017 , in

Tallahassee, Leon County, Florida.

S

J. LAWRENCE JOHNSTON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallahassee, Florida 32399 - 3060

(850) 488 - 9675

Fax Filing (850) 921 - 6847

www.doah.state.fl.us

Filed with the Clerk of th e

Division of Administrative Hearings

this 17 th day of November , 2017 .

ENDNOTE

1/ Unless otherwise noted, stat utory references are to the 2013

codification of the Florida Statutes, which was in effect at the

time of the alleged offense .

COPIES FURNI SHED:

Christopher R. Dierlam, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way , Bin C65

Tallahassee, Florida 32399

(eServed)

Natalia Thomas, Esquire

Department of Health

Prosecution Services Unit

4052 Bald Cypress Way , Bin C6 5

Tallahassee, Florida 32399

(eServed)

Jon M. Pellett, Esquire

The Doctors Company

Suite 401

12724 Gran Bay Parkway West

Jacksonville, Florida 32258

(eServed)

Claudia Kemp, JD, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypres s Way , Bin C03

Tallahassee, Florida 32399 - 3253

(eServed)

Nichole C. Geary, General Counsel

Department of Health

4052 Bald Cypress Way , Bin A02

Tallahassee, Florida 32399 - 1701

(eServed)

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to submit written exceptions within

15 days from the date of this Recommended Order. Any exceptions

to this Recommended Order should be filed with the agency that

will issue the Final Order in this case.