12-001143 Agency For Health Care Administration vs. Doctor`s Office For Women, Inc., D/B/A Today`s Women Medical Center Status: Closed Recommended Order on Tuesday, July 31, 2012.

Summary: Abortion clinic failed to obtain and maintain patient's consent for a procedure that clinic physician performed eight weeks after having performed an abortion on the patient.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

AGENCY FOR HEALTH CARE )

ADMINISTRATION, )

)

Petitioner, )

) Case No. 12 - 1143

vs. )

)

DOCTOR ' S OFFICE FOR WOMEN, )

INC., d/b/a TODAY ' S WOMEN )

MEDICAL CENTER , )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a hearing was conducted in this case on

June 8, 2012, by video teleconference at sites in Miami and

Tallahassee, Florida, before Administrative Law Judge (ALJ)

Claude B. Arrington of the Division of Administrative Hearings

(DOAH).

APPEARANCES

For Petitioner: Nelson E. Rodney, Esquire

Agency for Health Care Administration

Suite 300

8333 Northwest 53rd Street

Miami, Florida 33166

For Respondent: Vlad Van Rosenthal, M.D.

Q ualified Representative

Doctor's Office for Women

3250 South Dixie Highway

Miami, Florida 33133

STATEMENT OF THE ISSUE

Whether Respondent, Doctor ' s Office for Women, Inc., d/b/a

Today ' s Women Medical Center (Respondent), failed to maintain

medical records as alleged in the Administrative Complaint filed

with DOAH on March 28, 2012.

PRELIMINARY STATEMENT

By Administrative Complaint filed February 7, 2012, the

Agency for Health Care Administration (Petitioner) allege d

certain facts pertaining to a n abortion performed on a female

patient (the Patient) . Bas ed on those factual allegations,

Petitioner charged Respondent with failing to maintain medical

records in violation of Florida Administrative Code Rule 59A -

9. 031 .

Respondent thereafter timely requested a formal

administrative hearing , the matter was referred to DOAH, and

this proceeding followed.

Prior to the formal hearing, Petitioner narrowed its

allegations against Respondent. Petitioner alleged that

Respondent violated the medical records rule by failing to

maintain a consent form for a procedure that was approximately

eight weeks after the Pa tient ' s abortion. Petitioner also

alleged that Respondent violated the medical records rule by

failing to obtain records of the Patient ' s visit to an emergency

room between the abortion and the subsequent procedure. All

other allegations were abandone d.

At the final hearing, Petitioner presented the testimony of

Ariesa Render, a nd Faith Randolph. Ms. Render is employed by

Petitioner as a Health Facility Evaluator. Ms. Randolph is

employed by Petitioner as a Registered Nurse Consultant.

Petitioner offered two exhibits, both of which were admitted

into evidence without objection. Respondent presented the

testimony of Vla d Van Rosenthal, M.D. , the owner and medical

director of the subject facility. Respondent offered no

exhibits .

A Transcript of the hearing was filed June 27, 2012.

Petitioner filed a timely Proposed Recommended Order (PRO),

which has been duly considered by the undersigned in the

preparation of this Recommended Order. Respondent did not file

a PRO.

FINDINGS OF FACT

1. At all times relevant to this proceeding, Respondent

has been licensed as an abortion clinic authorized to perform

first and second trimester abortions. The facility at issue in

this proceeding is located in Miami - Dade County , Florida.

2. Respondent is required to c omply with the following

provisions of Florida Administrative Code Rule 59A - 9.031 :

(1) A permanent individual clinical record

shall be kept on each clinic patient.

Clinical records shall be complete,

accurately documented, and systematically

organized to facilitate storage and

retrieval.

(a) Clinical records shall be complete,

accurately documented, and systematically

organized to facilitate storage and

retrieval.

(b) Clinical records involving second

trimester abortion procedures shall be kept

confidential and secure.

(c) Operative reports signed by the

physician performing the second trimester

abortion shall be recorded in the clinical

record immediately follow ing the procedure

or that an operative progress note is

entered in the clinical record to provide

pertinent information.

(2) Clinical records shall be kept on file

for a minimum of five years from the date of

the last entry.

3. At the times relevant to this proceeding, Respondent

used a consent form which, preceding the line for the patient to

date and sign the form, states as follows:

I, ________________, voluntarily authorize

Doctor ' s Office for Women, [ Dr. Rosenthal ] ,

who is an independent provider and will have

complete control over this procedure, follow

up and any and all treatments and who m oever

he may designate as his assistants, to

perform upon me an elective abortion. I

fully understand that the purpose of the

procedure is to terminate my pregnancy, and

I affirm this is to be my personal choice in

the light of the alternative of continuing

th e pregnancy to full term. I further

request and authorize him to do whatever he

deems advisable if any unforeseen conditions

arise in the course of the abortion that

call, in his judgment, for procedures in

addition to or different from those

contemplated .

I will fully and completely disclose my

medical history, including allergies, blood

conditions, prior medications or drugs

taken, and reactions I had to anesthesia,

medicines of [sic] drugs, I consume to my

physician relying on my disclosure to be

com plete.

I consent to the administration of

anesthesia as may be deemed necessary or

advisable by my physician. I understand

that local anesthesia do not eliminate all

pain completely and IV sedation anesthesia

(Versed, Valium, Demerol) will not put me to

sleep and no guarantee to the contrary have

been made to me.

The nature and purpose of an abortion, the

procedures, the risks involved, the

emotional distress, and the possibility of

complications have been fully explained to

me. I realize there are inhere nt risks of

minor and major complications which may

occur in this and all surgical procedures

without the fault of the physician. No

guarantee has been made to me. The

complications include, but are not limited

to: allergic reaction to the sedative or

a nesthesia; infection; excessive bleeding;

the need for a second D&C to complete the

abortion; perforation of the u terus;

laceration of the cervix; hysterectomy -

surgically removing the pregnancy through

the abdomen; removal of the uterus as

treatment of a complication (hysterectomy),

also, one study indicates the possibility of

breast cancer due to abortions even though

these studies are not conclusive, we still

recommend annual breast examinations, etc.

[sic].

I release the doctors and Doctor ' s Office

for Women and any corporation which operates

this facility from any liability resulting

from the above mentioned [sic] or any other

complications.

I further realize that I may need to be

hospitalized at my own expense for treatment

of such complications. I realize that such

conditions can be caused by my own condition

or conduct. I will accept hospitalization,

if required by the doctors for any

c omplications arising from this procedure.

I understand that my complication requiring

hospitalization, as a result of the

termination will not be covered financially

by the Doctor ' s Office for Women, or

corporation which m a y operate this facility

or the d octors.

I understand that any questions I have

will be answered before leaving the

facility. If I have any questions or

complications after leaving, I agree to call

the Doctor ' s Office at this number : [xxx -

xxx - xxxx].

I understand that I must return to the

office for a two - week post - termination

evaluation (free). I also acknowledge that

if I do not return for this evaluation, I

have not completed my medical care and

release the Doctor ' s Office for Women and

physicians from any liability resulting fr om

my termination.

The undersigned hereby expressly waives

and releases for themselves, heirs or

representatives any claim s or demand which

they may have of any nature, kind or

description agai nst [Dr. Rosenthal] and/or

his/her assistant/s and Doctor ' s Office for

Women, and any corporation which operates

this facility and the undersigned do [sic]

specifically assume any and all

responsibility for the operation,

acknowledging that the same is done at their

[sic] request for their benefits [sic]. I

certif y that (if married) I have notified m y

husband of my intention to obtain a

termination of pregnancy and I have given

him the opportunity to consult with me

concerning this decision. I CERTIFY THAT I

HAVE READ AND FULLY UNDERSTAND THE ABOVE

CONSENT TO AN A BORTION THAT THE EXPLANTAIONS

THEREIN REFERRED TO WERE MADE [sic]. I GIVE

THIS PERMISSION VOLUNTARILY AND OF MY OWN

FREE WILL, I FURTHER REPRESENT AND WARRANT

THAT I HAVE FULL LEGAL AUTHORITY TO GIVE

THIS PERMISSION.

4 . On July 18, 2011, the Patient executed the foregoing

consent form , and Dr. Rosenthal performed an abortion on the

Patient.

5 . On September 20, 2011, Ms. Render inspected the

Patient ' s medical records as maintained by Respondent a s part of

a survey of the facility.

6 . Respondent ' s records for the Patient reflect the events

of July 18, 2011. The Patient ' s records reflected that the

Patient was seen at an emergency room on a date between July 18

and September 13, 2011. The Patient ' s records did not reflect

the date of that visit to the emergency room . The Patient ' s

records reflect that the Patient had gone to the emergency room

due to excessive bleeding for a sustained period of time

following the abortion on July 18 , 2011 . The Patient ' s records

reflect t hat all findings at the emergency room were " WNL "

(within normal limits), but the records have no further

information as to the emergency room visit.

7. On September 13, 2011, the Patient returned to

Respondent ' s facility , at which time Dr. Rosenthal performed on

the Patient a procedure generally referred to as a D&C (dilation

and curettage). The Patient did not sign a separate consent

form for the second procedure.

8. Ms. Randolph ' s testimony, and the consent form itse lf,

established that the consent form authorized emergency follow - up

care for the abortion, but it was insufficient to authorize the

D&C some eight weeks after the abortion. Petitioner established

that Respondent should have obtained written consent for t he

second procedure and should have maintained that consent as part

of the Patient ' s records. 1 /

CONCLUSIONS OF LAW

9. The Division of Administrative Hearings has

jurisdiction over the subject matter of and the parties to this

proceeding pursuant to sectio ns 120.569 and 120.57(1).

10 . The burden of proof is on Petitioner to prove the

material allegations of its Administrative Complaint by clear

and convincing evidence. Dep ' t of Banking & Fin. v. Osborne

Stern & Co., Inc. , 670 So. 2d 932 (Fla. 1996).

11 . Respondent ' s records noted that the emergency room

visit occurred and noted th at all findings were " WNL. "

Petitioner did not prove that Respondent was required to obtain

a copy of the records of the Patient ' s emergency room visit or

further document the findings of that visit. Consequently, no

violation should be predicated on the absence of emergency room

records.

12. Although the second procedure may have been necessary

because of the first procedure, they are two separate and

dis tinct procedures separated in time by eight weeks.

Petitioner proved that Respondent should have obtained a

separate consent from the Patient for the second procedure ,

which should have been maintained in the Patient ' s medical

records as alleged by the Ad ministrative Complaint. The failure

to maintain a valid consent form for the second procedure

violated Florida Administrative Code Rule 59A - 9.031 , as alleged

by the Administrative Complaint .

13. Pursuant to section 390.018, Petitioner has the

authority to impose upon Respondent an administrative fine for

the violation found up to $1,000.00 , which is the amount of the

fine requested by Petitioner in its PRO . Considering the

importance of obtaining consent and ma intaining accurate records

in a medical fa cility , the undersigned concludes that a penalty

of $1,000.00 is appropriate.

RECOMMENDATION

Based upon the foregoing Findings of Fact and Conclusions

of Law, it is hereby RECOMMENDED that the Agency for Health Care

Administration enter a final order finding Respondent guilty of

failing to maintain a consent form for the second procedure, but

dismissing all other charges against A Doctor ' s Office for

Women, Incorporated, d/b/a Today ' s Women Medical Center. It is

further recommended that the final orde r impose an

administrative fine in the amount of $1,000.00 against A

Doctor ' s Office for Women, Incorporated, d/b/a Today ' s Women

Medical Center.

DONE AND ENTERED this 31st day of July, 2012, in

Tallahassee, Leon County, Florida.

S

CLAUDE B. ARRINGTON

Div ision 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 the

Division of Administrative Hearings

this 31st day of Jul y, 2012.

ENDNOTE

1 / In making these findings, the undersigned has considered

Dr. Rosenthal ' s testimony. Dr. Rosenthal testified, credibly,

that the Patient was not billed for the second procedure. He

further testified that he did not believe the Patient needed to

sign a separate consent form for the second procedure because of

the consent form signed by the Patient on July 18, 2011.

Dr. Rosenthal considered the Patient to have consented to the

D&C performed on September 13 as follow - up treatment for the

abortion performed July 18, 2011.

COPIES FURNISHED :

Richard J. Shoop, Agency Counsel

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 3

Tallahassee, Florida 32308

Stuart Williams, General Counsel

Agency for Health Care Adminis tration

2727 Mahan Drive, Mail Stop 3

Tallahassee, Florida 32308

Elizabeth Dudek, Secretary

Agency for Health Care Administration

2727 Mahan Drive, Mail Stop 1

Tallahassee, Florida 32308

Nelson E. Rodney, Esquire

Agency for Health Care Administration

Suite 300

8333 Northwest 53rd Street

Miami, Florida 33166

Vlad Van Rosenthal, M.D.

Qualified Representative

Doctor ' s Office for Women

3250 South Dixie Highway

Miami, Florida 33133

NOTICE OF RIGHT TO SUBMIT EXCEPTIONS

All parties have the right to sub mit 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.