12-000666PL Department Of Health, Board Of Medicine vs. Neelam T. Uppal, M.D. Status: Closed Recommended Order on Tuesday, September 4, 2012.

Summary: One charge of practice in unsanitary conditions sustained; other charges regarding storage of medications not proven. Recommend letter of concern and $1,000 fine.

STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF )

MEDICINE , )

)

Petitioner , )

)

vs. ) Case Nos. 12 - 0666PL

)

NEELAM T. UPPAL, M.D. , )

)

Respondent . )

)

RECOMMENDED ORDE R

On June 19, 2012, a disputed fact administrative hearing was

held in this case by video teleconference in Tallahassee and

St. Petersburg, Florida, before J. Lawrence Johnston,

Administrative Law Judge, Division of Administrative Hearings

(DOAH).

APPEARA NCES

For Petitioner: Elana J. Jones, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

For Respondent: Michael R. D ' Lugo, Esquire

Wicker, Smith, O ' Hara,

McCoy and Ford, P.A.

Post Office Box 2753

Orlando, Florida 32802

STATEMENT OF THE ISSUE

The issue in this case is whether the Board of Medicine

should di scipline Respondent under section 458.331(1)(g), Florida

Statutes (2006), 1/ for failures to perform statutory or legal

obligations allegedly revealed during an inspection of her

medical practice on March 17, 2007. Respondent denies the

charges and also de fends on the ground of laches.

PRELIMINARY STATEMENT

On March 12, 2008, Petitioner, the Department of Health

(DOH), filed the Administrative Complaint resulting from the

inspection on March 17, 2007. Respondent timely disputed the

facts and requested a hearing. The matter was not referred to

DOAH until February 12, 2012, after failed attempts to settle

this and another a dministrative c omplaint against Respondent (for

allegedly facilitating the unlicensed practice of medicine by her

medical assistant). (The other a dministrative c omplaint also was

referred to DOAH and was consolidated with this case, but later

was severed and closed, and jurisdiction was relinquished to

allow the Board of Medicine to reconsider probable cause.)

At the final hearing on Jun e 19, 2012 (which was governed by

the parties ' Second Amended Joint Pre - hearing Stipulation), DOH

called Benjamin Simpkins, Karen Hanzal, and Mary Mayleben,

Pharm.D., as witnesses and had Petitioner ' s Exhibits 1 through 5 ,

7 , and 8 admitted in evidence. Respondent testified and had

Respondent ' s Exhibits 1, 15, 17, and 22 admitted in evidence.

On June 22, DOH moved unopposed for leave to file an Amended

Administrative Complaint to correct two minor errors, which was

granted.

The Transcript of the final h earing was filed on July 11.

On August 10, the parties filed proposed recommended orders,

which have been considered.

FINDING S OF FACT

1. Respondent holds license ME 59800, which allows her to

practice medicine in Florida, subject to regulation by DOH an d

the Board of Medicine. In March 2006, it was noted on

Respondent ' s license that she was a dispensing practitioner,

meaning that she could sell or dispense medication. Her medical

office at the time was at 5840 Park Boulevard in Pinellas Park.

2. Respo ndent has been practicing medicine in Florida since

1998. She has not been disciplined by the Board of Medicine.

Her practice treats patients for infectious diseases. She often

is referred patients who cannot be treated effectivel y by their

regular inte rnists.

3. Although licensed as a dispensing practitioner,

Respondent actually has not been operating as a dispensing

practitioner. She was not purchasing medications for resale to

her patients. (She sometimes gives her patients free samples.)

Rather, Respondent stores at her office medications purchased by

her patients in large quantities to save money. Sometimes,

patients bring their medications to Respondent; sometimes, an

online pharmacist sends her patients ' medications directly to

Respondent ' s me dical practice. Respondent keeps the medications

in her office until the patients come in for treatment by

infusion or injection. If enough of a reusable medication

remains after infusion or injection, Respondent will store the

left - over medication, some times in a refrigerator or freezer, for

subsequent reuse. Respondent has no wholesale contracts for

medications and is not affiliated with an y manufacturer of

medications.

4. Respondent ' s medical office is in a two - story building.

The patient lobby and reception area, Respondent ' s personal

office, and several infusion and examination rooms are on the

first floor. The second floor is used to store medications.

Every three to four weeks, an employee sweeps the office for

expired medications and puts them in storage on the second floor.

A biohazard removal service comes to the office once a month to

remove and dispose of discarded sharps, used non - reusable

medications, and expired medications.

5. DOH conducted a routine inspection of Respondent ' s

medical practice i n February 2007. The practice was rated

satisfactory in all 28 elements of the inspection, including:

clean and safe dispensing area; proper storage of medications

requiring refrigeration; expiration/discard date of prescription

labels provide d in written form; no controlled substances; and

outdated medications removed from stock satisfactorily.

Respondent ' s medical practice also was subject to periodic

Medicaid inspections and biohazard inspections that were passed

satisfactorily .

6. At some time before March 17, 2007, DOH received a

complaint that Respondent ' s patients were being seen and treated

by unlicensed medical assistants on Saturdays when Respondent was

not present. On Saturday, March 17, 2007, Pinellas Park police

and DOH inspector s " raided " the practice. After making sure it

was safe to discontinue and postpone patient treatments , DOH

ordered all patient treatment to stop and ordered all patients to

leave the building. The police officer took photographs of the

medical practice. The inspection and photographs resulted in the

charges leveled against Respondent in this case. (They also

resulted in charges that Respondent facilitated the unlicensed

practice of medicine, but DOAH jurisdiction over those charges

was relinquished to a llow the Board of Medicine to reconsider

probable cause.)

Findings as to Count I

7. Count I of the Amended Administrative Complaint alleges

that Respondent violated Florida Administrative Code Rule 64B16 -

28.110 by failing to remove expired and deteriorate d medications

from her stock of medications at least every four months and by

selling or d ispensing expired medications.

8. On March 17, 2007, there were some expired and

deteriorated medications at Respondent ' s medical practice. The

deteriorated medicat ions were partially or almost completely used

medications. In some cases, it was unclear whether the

expiration date was a prescription expirati on or a medication

expiration.

9. One medication bore an expiration date of 1994. There

was no rational expla nation for how that date came to be on the

medication since Respondent was in New Jersey then and was not

practicing m edicine in Florida until 1998.

10. Except for possibly the mysterious medication bearing

the 1994 expiration date, there was no proof tha t any medications

were expired for more than four months. To the contrary, the

evidence was that there were no expired medications in s torage as

of February 7, 2007.

Findings as to Count II

11. Count II of the Amended Administrative Complaint

alleges tha t Respondent violated section 499.005(1), Florida

Statutes, by storing medications in a freezer that were not

supposed to be stored that way, or by possessing legend drugs for

which she could not produc e pedigree papers.

12. The evidence proved that Respo ndent stored medications

in a freezer that were labeled " refrigerate. " The evidence did

not prove that those medications were not allowed to be stored in

a freezer , or that storage in a freezer would adulterate the

medication or render it unfit for use. To the contrary, there

was evidence that, for at least one of the medications being

stored in a freezer (ceftriaxone, generic for Rocephin), freezing

can extend the useful life of the medication for up to 26 weeks.

As DOH points out, it cannot be assumed that the same is true of

another medication (Azactam) found in a freezer at Respondent ' s

medical practice and labeled " refrigerate. " But DOH did not

prove that the useful life of Azactam cannot be extended by

freezing .

13. DOH proved that Respondent coul d not produce pedigree

papers for any of the medications found at Respondent ' s medical

practice on March 17, 2007. It would not be expected that

Respondent would have pedigree papers for medications purchased

by her patients from other pharmacies and stor ed at Respondent ' s

office for their convenience. Those pedigree papers would be

held by the pharmacies that sold the medications to the patients.

Since Respondent was not acting as a dispensing practitioner, she

was not receiving pedigree papers and did not even know wha t they

were on March 17, 2007.

Findings as to Count III

14. Count III of the Amended Administrative Complaint

alleges that Respondent violated rule 64B8 - 9.0075 by leaving a

syringe, or allowing a syringe to be left, on the counter in the

reception area of her office, or by storing or allowing

medications to be stored in a refrigerator with uneaten food in a

McDonald ' s bag.

15. Respondent herself was not physically present at her

medical office on March 17, 2007, which was a Saturday, bef ore

the arrival of the police and DOH inspectors.

16. There was a syringe left on the counter in the

reception area of Respondent ' s office that was photographed by

the police officer and seen by him and the DOH inspectors. There

was no evidence as to the circumstances of how or when the

syringe came to be there. It is possible that it was left there

by someone who was interrupted in the provision of medical

services by the raid that morning. It was not proven that, as a

result of the syringe left on the counter, Respondent was not

providing appropriate medical c are under sanitary conditions.

17. On March 17, 2007, medications were being stored in a

refrigerator with a McDonald ' s bag that had food in it. There

was no evidence as to the circumstances of how or when the bag of

food came to be in the refrigerator, but it was unlikely that it

was placed there because of the raid that day, and it was

inappropriate to store medications in the r efrigerator with the

food bag.

18. There was other evidence that R espondent ' s medical

practice was not providing patients with appropriate medical care

under sanitary conditions. Open vials and injection and infusion

devices lay on unsanitary shelves and other surfaces.

Refrigerators and freezers where used medications and infusion

and injection devices were being stored were not cleaned

appropriately. Floors were not cleaned appropriately. However,

those items were not specifically charged in the Ame nded

Administrative Complaint.

Findings as to Count IV

19. Count IV of the Amended Administrative Complaint

alleges that Respondent violated section 456.057 , Florida

Statu t es, by maintaining patient records in an unlocked file

cabinet in an examination room, or by maintaining medical records

(or allowing them to be mainta ined) in plain view of anyone who

approached the reception area of Respondent ' s office.

20. DOH proved that there were records stored in an

unlocked cabinet in one of Respondent ' s examination rooms, but it

was not proved that they were patient records. N either the

police officer nor any inspector looked at the records to

ascertain what they were. Respondent testified that they were

administrative records, not confidential patient records.

21. There were patient files left lying on the shelf of the

half - door between the patient lobby and waiting area and the

reception desk of Respondent ' s medical practice. There also were

open files on the reception desk that possibly could have been

seen and read (upside down) by someone standing at the counter in

front of the reception desk. These files were photographed by

the police officer and seen by him and the DOH inspectors. There

was no evidence as to the circumstances of how or when the files

got there. It is possible that they were left there by someone

who was interrupted in the provision of medical services by the

raid that morning.

Respondent ' s Defenses

22. Respondent contends that the photographs taken at her

office on March 17, 2007, were " staged " -- i.e., that the charges

were trumped up by moving or pl acing items to be photographed

(including the McDonald ' s bag) to make it appear that Respondent

was in violation when she was not. The police or DOH

investigators did not stage the photographs. Respondent herself

testified that she did not believe her me dical assistant and

other office staff would have done so. That leaves only her

medical assistant ' s boyfriend, who may have been there on

March 17, 2007. No plausible reason was given why the boyfriend

would have done such a thing (although it is conceiv able that he

might have placed a McDonald ' s bag in the refrigerator).

23. Part of Respondent ' s case that violations were staged

was the hearsay of a patient who was there on March 17, 2007.

Respondent testified that, when she arrived at the office during

the raid, the patient told her she was being " set up, " that he

saw patient files being placed in open view on countertops and

saw someone enter the back door with coffee and food that was

placed in the refrigerator. She says he told her that he would

tes tify to what he saw in her defense .

24. Respondent also contends that laches bars the Amended

Administrative Complaint because the employee assigned to monitor

and discard expired medications and the patient whose hearsay

claimed Respondent was set up hav e died. There was no evidence

as to when these individuals died, or why Respondent was unable

to preserve their testimony before they died.

25. The Administrative Complaint was filed in March 2008.

Respondent requested a disputed fact hearing in April 2 008. No

evidence was presented at the hearing as to why the matter was

not referred to DOAH until February 2012. DOAH files, which can

be officially recognized, indicate that at least some of the

delay related to settlement negotiations and the considera tion of

settlement proposals through August 2008.

26. In October 2008 and again in 2011, Respondent ' s office

computer systems malfunctioned, resulting in the loss of digital

patient appointment records for March 2007. No evidence was

presented at the hea ring as to how DOH is responsible for this

loss or how the loss of patient appointment records prejudiced

Respondent in the presentation of her defense.

CONCLUSIONS OF LAW

27 . Section 458.331(1)(g) authorizes the Board of Medicine

to discipline a Florida - licensed physician who fails to perform

any statutory or legal obligation placed upon a licensed

physician.

28. Because it seeks to impose license discipline, DOH has

the burden to prove its allegations by clear and convincing

evidence. See In re Davey , 645 So. 2d 398, 405 (Fla. 1994);

Dep ' t of Banking & Fin. v. Osborne Stern & Co., Inc. , 670 So. 2d

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

1987).

29. Count I of the Amended Administrative Complaint alleges

that Respondent violated rule 64B16 - 28.110. That rule governs

pharmacies and dispensing practitioners and states:

Persons qualified to do so shall examine the

stock of the prescription department of each

pharmacy at a minimum interval of four

months, and shall remove all deteriorate d

pharmaceuticals, or pharmaceuticals which

bear upon the container an expiration date

which date has been reached, and under no

circumstances will pharmaceuticals or devices

which bear upon the container an expiration

date which has been reached be sold o r

dispensed to the public.

30. DOH did not prove either that Respondent did not have a

qualified person examine prescriptions at least every four months

and remove all deteriorated and expired pharmaceuticals, or that

Respondent sold or dispensed expir ed medications to the public.

31. Count II of the Amended Administrative Complaint

alleges that Respondent violated section 499.005(1) , Florida

Statutes, by storing medications in a freezer that were not

supposed to be stored that way, or by possessing le gend drugs for

which she could not produce pedigree papers. Expired drugs are,

by definition, adulterated; so are legend drugs for which the

required pedigree paper is nonexistent, fraudulent, or

incomplete. § 499.006(9) - (10), Fla. Stat .

32. DOH did not prove either that Respondent stored

medications in a freezer that were not supposed to be stored that

way, or that Respondent did not have pedigree papers that she was

supposed to have.

33. Count III of the Amended Administrative Complaint

alleges that R espondent violated rule 64B8 - 9.0075 by leaving a

syringe, or allowing a syringe to be left, on the counter in the

reception area of her office, or by storing or allowing

medications to be stored in a refrigerator with a bag of fast

food. The rule requires licensed physicians to ensure that their

patients are provided appropriate medical c are under sanitary

conditions.

34. DOH proved that on March 17, 2007, a syringe was on the

counter in the reception area and that medications were stored in

a refrigerato r with a bag of fast food. DOH did not prove the

circumstances of how or when either the syringe or the bag of

fast food came to be where they were on March 17, 2007. As a

result, the syringe did not clearly prove inappropriate provision

of medical care under less - than - sanitary conditions. On the

other hand, the storage of medications alongside a food bag in a

refrigerator did prove a violation .

35. There was other evidence that Respondent ' s medical

practice was not providing patients with appropriate m edical care

under sanitary conditions. However, those items were not

specifically charged in the Amended Administrative Complaint, and

discipline cannot be based on them. See Trevisani v. Dep ' t of

Health , 908 So. 2d 1108 (Fla . 1st DCA 2005); Aldrete v. D ep ' t of

Health, Bd. of Med . , 879 So. 2d 1244 (Fla. 1st DCA 2004); Ghani

v. Dep ' t of Health , 714 So. 2d 1113 (Fla. 1st DCA 1998); Willner

v. Dep ' t of Prof ' l Reg., Bd. of Med . , 563 So. 2d 805 (Fla. 1st

DCA 1990) .

36. Count IV of the Amended Administrative C omplaint

alleges that Respondent violated section 456.057 by maintaining

patient records in an unlocked file cabinet in an examination

room, or by maintaining medical records in plain view of anyone

who approached the reception area.

37. It was proven tha t during the raid on Respondent ' s

medical practice on March 17, 2007, medical records were left in

places where they could be seen, but they could have been left

there by someone who was interrupted in the provision of medical

services by the raid that mor ning. For that reason, the all eged

violation was not proven.

38. Respondent did not prove her defense that she was set

up. She also did not prove her defense of laches .

39. Technically, laches does not apply to administrative

license discipline cases. See Farzad v. Dep ' t of Prof ' l Reg.,

Bd. of Med . , 443 So. 2d 373 (Fla. 1st DCA 1983). Procedural

delays contrary to statute can result in dismissal if the delays

impair the fairness of the proceedings or the correctness of the

action taken and prejudice t he licensee. See Carter v. Dep ' t of

Prof ' l Reg., Bd. of Optometry , 613 So. 2d 78 (Fla. 1st DCA 1993).

In this case, under section 456.073(2) , DOH was to have completed

the report of its initial investigative findings and

recommendations concerning probab le cause within six months of

March 17, 2007, but there was no evidence that the delay

prejudiced Respondent in any way. No evidence was presented at

the hearing as to why the referral to DOAH was delayed from

April 2008 until February 2012. DOAH files, which can be

officially recognized, indicate that at least some of the delay

was related to settlement negotiations and proposals.

40. The alleged unfairness was due to the death of two

witnesses. No evidence was presented as to when the two

witnesses di ed, or why Respondent was unable to preserve their

testimony. For these reasons, dismissal is not an appropriate

consequence of the delay in referring the matter to DOAH.

41. Respondent also asserted that the loss of digital

patient appointment records d uring the delay in referring the

matter to DOAH resulted in unfairness to Respondent. No evidence

was presented at the hearing as to whether Respondent was

prejudiced in any way from the loss of digital patient

appointment records during the delay in refe rring the matter to

DOAH. In any event, it was Respondent ' s duty to maintain these

records. See §§ 458.331(1)(g) & (m) & 456.057, Fla. Stat.; Fl a.

Admin. Code R. 64B8 - 10.002.

42. Under rule 64B8 - 8.001(g), the recommended ranges of

penalties for the prov en violation alleged in Count III are from

a letter of concern to revocation and an administrative fine from

$1,000 to $10,000. Based on the severity of the offense and the

potential for patient harm, the lower quartile of the penalty

range is appropriate . Consideration of the aggravating and

mitigating factors in paragraph (3) of the rule makes a penalty

at the low end of the range appropriate in this case.

RECOMMENDATION

Based on the foregoing Findings of Fact and Conclusions of

Law, it is

RECOMMENDED that the Board of Medicine enter a final order:

finding Respondent guilty of one of the violations alleged in

Count III of the Amended Administrative Complaint, but not guilty

of the other charges; issuing a letter of concern; and imposing a

$1,000 fine.

DONE AND ENTERED this 4 t h day of September , 2012 , in

Tallahassee, Leon County, Florida.

S

J. LAWRENCE JOHNSTON

Administrative Law Judge

Division of Administrative Hearings

The DeSoto Building

1230 Apalachee Parkway

Tallah assee, 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 4th day of September , 2012 .

ENDNOTE

1/ All statutory references are to the 2006 Florida Statu tes,

which were in effect at the time of the alleged violations.

Likewise, all rule references are to the revision of the Florida

Administrative Code in effect at the time of the alleged

violations.

COPIES FURNISHED:

Michael R. D ' Lugo, Esquire

Wicker, Smith, O ' Hara,

McCoy and Ford, P.A.

Post Office Box 2753

Orlando, Florida 32802

Elana J. Jones, Esquire

Department of Health

4052 Bald Cypress Way, Bin C - 65

Tallahassee, Florida 32399 - 3265

Jennifer A. Tschetter, General Counsel

Department of Health

4 052 Bald Cypress Way, Bin A - 02

Tallahassee, Florida 32399 - 1701

Joy Tootle, Executive Director

Board of Medicine

Department of Health

4052 Bald Cypress Way

Tallahassee, Florida 32399 - 1701

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.