STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, ) BOARD OF OSTEOPATHIC MEDICINE, )
)
Petitioner, )
)
vs. ) Case No. 05-1238PL
)
SHELLY O. WOLLAND, D.O., )
)
Respondent. )
)
RECOMMENDED ORDER
Pursuant to notice, a formal hearing was held in this case before Larry J. Sartin, an Administrative Law Judge of the Division of Administrative Hearings, in Miami, Florida, on August 10 and 11, 2005.
APPEARANCES
For Petitioner: Ellen M. Simon
Kurt L. Barch
Assistants General Counsel Prosecution Services Unit Office of the General Counsel Department of Health
4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265
For Respondent: Joseph S. Paglino, Esquire
Law Offices of Joseph S. Paglino 12865 West Dixie Highway
North Miami, Florida 33161
STATEMENT OF THE ISSUE
The issue in this case is whether Respondent, Shelly O. Wolland, D.O., committed the violations alleged in an Administrative Complaint dated April 12, 2002, issued by Petitioner, the Department of Health, in DOH Case No. 2001- 16871, and, if so, what disciplinary action should be taken
against her.
PRELIMINARY STATEMENT
In a two-count Administrative Complaint dated April 12, 2002, DOH Case No. 2001-16871, Petitioner alleged that
Dr. Wolland violated two statutory provisions governing the practice of health care practitioners in Florida, Section 459.015(1)(t) and (x), Florida Statutes (2002). On or about April 23, 2002, Dr. Wolland executed an Election of Rights form disputing the allegations of material fact contained in the Administrative Complaint and requested a formal administrative hearing.
On April 6, 2005, Petitioner filed the Administrative Complaint and Dr. Wolland's request for hearing with the Division of Administrative Hearings for assignment of an administrative law judge to conduct an evidentiary hearing.1 The matter was designed DOAH Case No. 05-1238PL and was assigned to the undersigned.
On April 18, 2005, a Notice of Hearing was entered scheduling the final hearing of this matter for June 21 through 24, 2005. The final hearing was subsequently rescheduled to August 10 through 12, 2005.
Also on April 18, 2005, Dr. Wolland moved for the consolidation of this case with DOAH Case No. 05-0860PL, DOH Case No. 2004-50416, the other case in which Dr. Wolland was named as Respondent then pending before the Division of Administrative Hearings.2 That motion was denied by Order entered April 26, 2005.
Both parties filed unilateral pre-hearing statements.
Dr. Wolland admitted certain facts in her pre-hearing statement, which have been included in this Recommended Order to the extent relevant.
At the final hearing, Petitioner presented the testimony of Luis Albuerne, David B. Schue, Raymond Alamo, Sandra Lozowicki, John D. Eller, Mary Ghabrial, and Jose Rose, D.O., accepted as an expert witness. Petitioner also had admitted Petitioner's Exhibits numbered 1, 1A and 2 through 12. Dr. Wolland testified on her own behalf. She also had six exhibits marked for identification. Dr. Wolland requested that official recognition be taken of Respondent's composite Exhibit 1.3 Over objection of Petitioner, it was concluded that official recognition would be taken if Dr. Wolland filed a certified copy of the exhibit.4 A
ruling on Petitioner's relevancy objection was reserved. Respondent's Exhibits 2 and 3 were not offered. Finally, Respondent's Exhibits 4 through 6 were rejected. They were proffered.
On August 18, 2005, Dr. Wolland filed Respondent's Notice of Filing Certified Copy of the Plea Agreement of Myra Williams Wright - and Her Annexed Statement to Medicaid Fraud Investigators Thomas Vicente, Richard Bowden and Raymond Alamo. These documents are Respondent's composite Exhibit 1.
Petitioner filed Petitioner's Response to Respondent's Notice of Filing Documentation. Petitioner raised objections to the admissibility of the documents and requested that they be struck. The documents, however, are simply the certified copy of Respondent's composite Exhibit 1 which the undersigned at hearing indicated Dr. Wolland could late-file. They are documents for which official recognition has been taken, to the extent ultimately determined to be relevant.
A Notice of Filing of Transcript was issued September 8, 2005, informing the parties that the Transcript of the final hearing had been filed with the Division and that they had until September 28, 2005, to file proposed recommended orders.
Dr. Wolland filed Respondent's Proposed Recommended Order on September 23, 2005. Petitioner filed Petitioner's Proposed Recommended Order on September 29, 2005.5 The Proposed
Recommended Orders have been fully considered in rendering this Recommended Order.
FINDINGS OF FACT
The Parties.
Petitioner, the Department of Health (hereinafter referred to as the "Department"), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice osteopathic medicine in Florida.
Respondent, Shelly O. Wolland, D.O., is, and was at the times material to this matter, an osteopathic physician licensed to practice osteopathic medicine in Florida, having been issued, on September 30, 1987, license number OS 5378.
On November 29, 2001, and at all times relevant to this proceeding, Dr. Wolland worked as an osteopathic physician at Sunshine Medical, Inc. (hereinafter referred to as "Sunshine"), located at 1498 Northwest 54th Street, Miami, Florida 33142.
Dr. Wolland's Practice.
For approximately ten years prior to 2001, Dr. Wolland had worked as a physician at Florida Park Health Center, the predecessor of Sunshine. She purchased the assets of Florida Park Health Center in January 2001.
Dr. Wolland's practice at the times relevant consisted of "an intercity family practice with a very large pediatric
practice, also a very large HIV, AIDS practice." Transcript, page 604, lines 20-23. Dr. Wolland was involved in the treatment of "over 200 AIDS patients," who "came in once a week to once a month." Id.
Dr. Wolland dealt primarily with the adult patients who presented to Sunshine, including those with HIV and AIDS, while her brother, Steve Ozapoff, a physician's assistant, was responsible for the initial treatment of pediatric patients. Dr. Wolland employed a staff of between nine and 12 employees.
C Operation Clean Clinic.
During the Fall of 2001, the Medicaid Fraud Control Unit, Office of the Attorney General (hereinafter referred to as the "MFCU"), was engaged in an investigative operation dubbed "Operation Clean Clinic."
The "mission" of Operation Clean Clinic was to inspect medical clinics or offices involved in the provision of Medicaid services in Florida to ensure that each clinic or office inspected and all personnel employed by an inspected clinic or office were properly licensed, and that Medicaid recipients and others were being provided quality care by the inspected clinic or facility.
Operation Clean Clinic inspections were performed by "teams," made up of a commander and several investigators, all
of whom had specific assigned tasks to carry out during an inspection.
The Miami Bureau of the MFCU performed its first Operation Clean Clinic inspection in November 2001. That inspection was performed at Sunshine on November 29, 2001.
The November 29, 2001, Inspection Team.
The inspection team that conducted the Operation Clean Clinic inspection of Sunshine on November 29, 2001, was commanded by Lieutenant Tom Vicente. Because this was the first inspection conducted by the Miami Bureau MFCU, Lieutenant Luis Albuerne assisted. While Lieutenant Albuerne testified, Lieutenant Vicente did not.
The inspection team that day also included the following Investigators:6 Sandra Lozowicki; John D. Eller; Raymond Alamo; Richard Baudin; and David B. Schue. With the exception of Investigator Baudin, all testified at the final hearing.
The duties of the Investigators included the following:
Inspector Lozowicki was the Senior Investigator. She was responsible for coordinating and supervising the efforts of the other investigators. Inspector Lozowicki ultimately assisted in the inventorying of medications found at Sunshine and in questioning and obtaining a statement from Dr. Wolland;
Inspector Eller was assigned the responsibility of assisting in making copies of documents and assisting Investigator Schue. Ultimately he also assisted in the inventorying of medications found at Sunshine;
Inspector Alamo was assigned the responsibility for taking photographs; and
Inspector Schue was responsible for making a to-scale drawing of Sunshine's offices. His drawing and a blow-up thereof, were accepted as Petitioner's Exhibits 1 and 1A. (All references to rooms in this Recommended Order will be to the names used by Inspector Schue on those exhibits to identify rooms).7
Inspector Baudin did not testify and, therefore, his overall duties were not described. He did, however, participate in questioning Dr. Wolland.
The General Conduct of the Inspection.
The Operation Clean Clinic inspection of Sunshine was initiated between 10:00 to 10:30 a.m., November 29, 2001.
Lieutenants Vicente and Albuerne entered the facility, leaving the rest of the inspection team outside. They introduced themselves to Dr. Wolland and explained the purpose of their inspection. Dr. Wolland, who had been informed by letter from the MFCU that an inspection would be made at some
unspecified time in the future,8 was cooperative and provided all assistance requested by the inspection team.
Lieutenant Albuerne described his initial conduct upon entering Sunshine, in part, as follows:
. . . . Like I said, when I first went in, the first thing I did is, I spoke with Dr. Wolland.
Q. Right. And then after you did that, did you call the other investigators in right away, or had you looked over the premises before ---
A. No. When I first met with Dr. Wolland, it took a little while, because I wanted to make sure that she understood what I needed and the personnel that I was going to need from her, in order to facilitate getting their records that we were going to need. Once that was accomplished, you know, and she told me that she would provide somebody, that's then when I brought the team in.
Transcript, page 44, lines 11-22.
After meeting with Dr. Wolland, which "took a little while" according to Lieutenant Albuerne, the rest of the team was brought into the facility. According to the Investigative Note written by Inspector Lozowicki on or about December 17, 2001, "Lieutenants Thomas Vicente and Luis Albuerne identified themselves and about 30 minutes later, the team entered the premises." Upon entering the premises, in addition to the members of the team independently making their way throughout the facility to carryout their assigned duties, Lieutenant
Albuerne, as he described it, made an initial "cursory walk- through of the facility."
During his walk-through, Lieutenant Albuerne observed a refrigerator located in the Medication Storage Laboratory which contained plastic trays in which unlabeled syringes filled with a clear liquid were stored. He also observed numerous other medications in the Medication Storage Laboratory and the Infusion Preparation Room, including a number of expired medications and medications which had been dispensed to particular patients. Lieutenant Albuerne saw enough of what he believed were improperly labeled and/or stored medications to cause him to decide that the Department's Bureau of Pharmacy Services should be contacted. Lieutenant Albuerne explained his reason for contacting the Department:
I wanted to make sure that if those products were going to be dispensed, that they were, you know, properly labeled, and that they were, you know, in such a state that they could be used by, or be given to an individual or person.
Transcript, page 49, lines 13-17.
What Lieutenant Vicente did between the initial meeting with Dr. Wolland and when the rest of the inspection team came into Sunshine to carry out their assigned duties, was not accounted for during the hearing of this matter.
Inspector Lozowicki described her initial actions upon being called into Sunshine by the Lieutenants, in part, as
follows:
I believe we met with Dr. Wolland and then met with some of the staff to provide them the list of the Medicaid recipients whose files we needed pulled so we could start copying.
Q. At what point did you walk around the medical facility?
A. It might have been shortly after that.
Subsequently, Inspector Lozowicki was informed "either by one of the lieutenants or one of the investigators" that there was a room full of medication bottles. That room was the Infusion Preparation Room. Obviously, Inspector Lozowicki was not the first member of the inspection team to enter the Infusion Preparation Room and, consequently could not clearly and convincingly describe the unspoiled state of the medications stored there:
Q. Was there anybody else in this are you identified, the infusion preparation room, with all the medications out? Was there anybody else in that room when you walked by it?
A. I can't remember. I think so. I know I wasn't the first one to see it.
Transcript, page 177, lines 8-14. The Department has suggested that it was only about ten minutes after entering Sunshine that Inspector Lozowicki entered the Infusion Preparation Room. Even
if this estimate of time were accurate, which it is not, that means Inspector Lozowicki did not enter the Infusion Preparation Room until a minimum of 40 minutes after the two Lieutenants first entered Sunshine.
Eventually, Inspector Lozowicki spent the rest of the day assisting in an inventory conducted by the Department's Bureau of Pharmacy Services of medications found in the Infusion Preparation Room and participated in questioning and obtaining a statement from Dr. Wolland
Inspector Eller, shortly after entering Sunshine, was directed by one of the Lieutenants to wait at the front of the facility for the arrival of someone from the Department's Bureau of Pharmacy Services. That individual, pharmacist Mary Ghabrial, arrived at Sunshine at approximately 11:00 a.m.
After escorting Ms. Ghabrial into the facility, Inspector Eller then observed the Infusion Preparation Room and the Medication Storage Laboratory. Obviously, he was not the first one to enter these rooms. At least 30 minutes to an hour passed before Inspector Eller saw either room.
Inspector Eller spent the majority of the day assisting Ms. Ghabrial in inventorying medications found in the Infusion Preparation Room and the Medication Storage Laboratory.
Inspector Schue, who was responsible for measuring the facilities rooms, was primarily occupied with his responsibilities.
Finally, Inspector Alamo took photographs within the facility. He arrived in the Infusion Inspection Room and the Medication Storage Laboratory after other members of the inspection team. In fact, the inventory described, infra, had already commenced when he began taking the photographs accepted into evidence as Petitioner's Exhibits 2 and 3.
The Department's Inventory.
After arriving at Sunshine and being shown the medications that had been found in the Infusion Preparation Room and the Medication Storage Laboratory, Ms. Ghabrial, assisted by Inspectors Lozowicki and Eller, inventoried all of the medications found in both rooms.
The medications inventoried included unlabeled pre- filled syringes which contained a clear liquid. The content of those syringes was ultimately identified by Dr. Wolland during the inspection and, but for the contents of 200 syringes allegedly filled with Serostim, at hearing.
Also inventoried were medications described by Ms. Ghabrial as follows:
. . . . There were medications that had prescriptions -- I mean that had labels from pharmacies, dispensing pharmacies to
patients, to specific patients, and there were others in amber vials that had not labels, as well as there were two bags, as I recall, two red bags, the bags said Procrit on it [sic], and they had -- they were filled with syringes with clear liquid. . .
.
Transcript, page 352, line 25, and page 353, lines 1-9.
Ms. Ghabrial further described the "amber vials":
They're amber vials, usually used by pharmacies to dispense medication in them, but they had no labels, and they just had some pills that we couldn't identify, and some had like a handwritten white paper that said, that had the name of the drug on it, and the dosage, but no expiration date, no lot number, nothing else to identify it.
Transcript, page 354, lines 9-15.
The medications that appeared to have been dispensed by a pharmacy to a particular patient, included pharmacies, in addition to a pharmacy located in the same building as Sunshine, located in: Tampa, Florida; Chicago, Illinois; and Broward County, Florida. There was one that had been dispensed by the Miami-Dade County Health Department.
Many of the medications inventoried were expired medications.
The inventories completed by Ms. Ghabrial, Inspector Lozowicki, and Inspector Eller were properly identified and admitted into evidence as Petitioner's Exhibits 4 and 8. Other than the inventory taken by Inspector Lozowicki, who only took
inventory in the Infusion Preparation Room, which room and the location within a room the medications listed on the inventories were actually found was neither identified on the inventories nor through testimony or other evidence. As to Inspector Lozowicki's inventory, the evidence only proved the room in which the medications were found, but not their location within the room.
Dr. Wolland's Statement.
Late in the afternoon or early evening of November 29, 2001, Dr. Wolland was questioned by Inspectors Baudin and Lozowicki. She answered questions posed to her freely, without any coercion, threat, or promise.
She also gave a written statement, which she wrote herself after being administered an oath. Again, she gave this statement freely, without any coercion, threat, or promise.
While Dr. Wolland was asked to address certain issues in her written statement and the exact number of pre-filled syringes found by investigators, she was not told specifically what to write about those issues. For example, she was asked to explain why she had pre-filled syringes found in the Infusion Preparation Room and the Medication Storage Laboratory. She was also asked to explain why she had medications which had been dispensed to patients from various sources.
The Department's Failure to Prove Precisely Where Many Medications Were Stored.
There were two rooms at Sunshine where pharmaceuticals were found to be stored: the Infusion Preparation Room and the Medication Storage Laboratory. Other than boxes of Novolin, which is insulin, and the pre-filled syringes found at Sunshine, both of which are discussed, infra, the Department failed to prove precisely where "adulterated and expired" medications inventoried by the Department were located before the arrival of the inspection team (hereinafter, all medications found at Sunshine other than Novolin and the pre-filled syringes will be referred to as "Adulterated and Expired Drugs").
The precise location of the Adulterated and Expired Medications is crucial because some of the charges of the Administrative Complaint are based upon allegations of improper medication storage techniques utilized at Sunshine by Dr. Wolland. As to most of the medications found in the Infusion Preparation Room and in the Medication Storage Laboratory, their precise location was not proved clearly and convincingly and, therefore, the Department has failed to prove clearly and convincingly that the Adulterated and Expired Medications were improperly stored.
First, and most importantly, the Department has not proved clearly and convincingly that Adulterated and Expired
Medications found in the Infusion Preparation Room were simply improperly stored as opposed to being retained for destruction.
Dr. Wolland testified convincingly and credibly that, due to the condition of many of her patients, she often took medications from patients which had expired or for whatever reason, were no longer being taken by the patient, in order to prevent confusion as to what medications the patient should be taking and to prevent their use by others.9 Dr. Wolland described at hearing why she accepted unused bottles of medications from her patients:
I'm talking about AIDS patients, with full-blown AIDS, who are on maybe three, four, five anti-viral medications, plus meds for yeast, plus meds for toxins in the brain, plus meds for asthma, plus meds for blood pressure, plus meds to build their blood, plus there could be medication for their liver problems, and medication because of -- to prevent PFP, pneumonia, and they get hospitalized, and with the 12 bottles that they already have, there is [sic] now
20 bottles, and they don't know what is what.
They come in and say, Doc, I've got all these new meds, I don't know what they're for. They bring me their medications. I say, yes, yes, take this, take this, this is for your flush, this for your AIDS, this is for your AIDS, this is for your AIDS. I write on there, this for your heart, this is for -- you don't need this one, this one is making you sick, this one is contraindicated with that one. I do take them, I put them in a cabinet, lock them up, because if they took all of them together it cold kill them. And there is [sic] way too many bottles for
me to say to them, dump that one in the garbage. They can't tell, don't know Asythromane (Phonetic) from Clarthomane (Phonectic) from Calextra (Phonetic) from Averiad (Phonetic), et cetera.
Transcript, page 630, lines 22-25, and page 631, lines 1-20.
In her sworn written statement of November 29, 2001, Dr. Wolland gave the same reason for having such medications:
The AIDS patients have frequent oral medication changes, and are on multiple medications when I change a patients [sic] meds. I ask them to return to me their remaining unused bottles so they do not get confused and take the wrong meds when [they] have so many bottles. That is why I have a cabinet full of unused bottles so they do not get confused and take the wrong meds when [they] have so many bottle. That is why I have a cabinet full of expired, opened meds with patients names on most of them. .
. .
While Dr. Wolland readily admitted accepting and storing medications given to her from her patients, she also testified that she maintained those medications in a separate area of the cabinets located in the Infusion Preparation Room and that those medications were properly identified as being held for destruction and kept locked. While her testimony in this regard is not credited totally,10 her testimony as to keeping the medications in locked cabinets is.11
Dr. Wolland's testimony that the cabinets and the refrigerator in the Infusion Preparation Room were locked was consistent and convincing. That testimony was also supported by
Petitioner's Exhibit 3k, in which the latches for the locks on the cabinet doors can be seen; Petitioner's Exhibit 3m and 3ii, in which the latch for the refrigerator is visible; and Petitioner's Exhibit 3ii in which the latch and the opened lock can be seen on top of the refrigerator.
Even if Dr. Wolland's testimony was not credited as to the locked cabinets and the locked refrigerator located in the Infusion Preparation Room, it was the Department's burden to prove clearly and convincingly that they were not locked. This the Department failed to do, for no member of the inspection team who entered the Infusion Preparation Room was able to testify that there were no locks.12 In fact, all of the members of the inspection team who testified were unable to recall whether there were locks.
More importantly, the question of whether any medications were being held for destruction and were properly stored, was not one that Dr. Wolland was required to answer. It was not her burden to prove that any medications were properly stored for destruction; it was the Department's burden to prove clearly and convincingly that they were not. Testimony to the effect that "I don't recall seeing any medications identified as being held for destruction" does not meet that burden.
Given the fact that the evidence proved that
Dr. Wolland had a legitimate reason for accepting medications
from her patients which they no longer needed and the fact that she maintained them in a locked cabinet, even though
Dr. Wolland's testimony as to where precisely those medications were maintained by her was not convincing, the Department had the burden of proving that the Adulterated and Expired Medications it discovered in the Infusion Preparation Room were not those which were being held by Dr. Wolland for destruction. This the Department did not do.
Turning to the Medication Storage Laboratory, given the fact that it has not been proved that there were no improperly stored medications in the Infusion Preparation Room, the Department needed to prove in particular which Adulterated and Expired Medications were found in the Medication Storage Laboratory, where there was no suggestion that drugs were being held for destruction. This the Department failed to do: the inventory accepted in evidence in this case and the testimony concerning that inventory did not establish what Adulterated and Expired Medications were found there as opposed to the Infusion Preparation Room.
Ms. Ghabrial and Investigator Eller, the two individuals who conducted the inventory of the medications found in the Medication Storage Laboratory, were also involved in the inventory of the Infusion Preparation Room. While they both indicated that they found Adulterated and Expired Medications
and identified the pages of the inventory they completed which listed those medications, they failed to indicate which of those pages relate to which room. There general testimony about what they witnessed at Sunshine also did not explain what Adulterated and Expired Medications were found in which rooms. Therefore, given the fact that, by failing to distinguish between Adulterated and Expired Medications stored in the Medication Storage Laboratory and the Infusion Preparation Room, the Department has failed to prove clearly and convincingly what medications were not being properly stored for destruction.
The failure of the Department to meet its burden of proof stems from the fact that it failed to present testimony from the first member of the inspection team to have entered the Infusion Preparation Room and, more importantly, testimony as to the very first person to look into the locked cabinets of the Infusion Preparation Room. That person was in all likelihood, Lieutenant Vicente. According to Dr. Wolland's unrebutted and credited testimony, Lieutenant Vicente went through the clinic with her and requested that she unlock cabinets and the refrigerator located in the Infusion Preparation Room. This testimony has been credited.
Having likely been the individual who first witnessed what was in the cabinets in the Infusion Preparation Room, Lieutenant Vicente was the only person who could precisely
describe where medications were stored in those cabinets immediately before the inspection began. Every member of the inspection team who did testify, entered that room after others had been in there. They were not able, therefore, to testify clearly and convincingly that nothing they saw had been moved, rearranged, or otherwise modified. It is not even clear who entered the room second or, more importantly, what had transpired in the room before they did.
The photographs taken by Inspector Alamo on November 29, 2001, also do little to establish the state in
which the Adulterated and Expired Medications were stored. Only a few of those photographs have been clearly and convincingly shown to depict Adulterated and Expired Medications before they were moved from their original location, i.e., Petitioner's Exhibit 3d. The rest, while depicting medications found in the facility, do not depict the original state they were found in, as Inspector Alamo admitted:
Q. Okay. Well, do you remember the time you were in the clinic taking photographs?
A. No, sir.
Q. Approximately?
A. No, sir, I don't remember.
Q. Was it early morning until at night?
A. I don't recall the time.
. . . .
Q. Did you assemble and pose these containers, or whatever they are, before you took pictures?
A. On some of the pictures, not all of them.
Q. Who posed the products on the other pictures?
A. It may have been myself or other members on our team.
Q. Okay. And did you take those things out of the locked cabinets, or did somebody else do that?
A. I don't recall.
Transcript, page 91, lines 22-25; page 92, lines 1-25; and
page 93, line 1.
Even a cursory examination of the photographs shows why they are not helpful in solving this issue. The following are only a few examples:
Petitioner's Exhibit 3a shows syringes which had been taken out of the refrigerator;
Petitioner's Exhibit 3b and 3c show a tray of syringes with a hand pulling it out. These photos also show that medications which were located on the top shelf of the refrigerator as evidenced by Petitioner's Exhibit 3d have been removed;
Petitioner's Exhibits 3e and 3v depict syringes which had been removed from the refrigerator;
Petitioner's Exhibit 3f depicts insulin which Ms. Ghrabrial testified was found in a refrigerator;
Petitioner's Exhibit 3m depicts medications on top of the refrigerator located in the Infusion Preparation Room which are not depicted in Petitioner's Exhibit 3ii; and
Petitioner's Exhibit 3y depicts two plastic baskets of syringes on a shelf which in Petitioner's Exhibit 3z and 3aa are located on a counter top.
In summary, the Department has failed to prove clearly and convincingly that Adulterated and Expired Medications found and inventoried in the Infusion Preparation Room and the Medication Storage Laboratory on November 29, 2001, were not being held for destruction.
The Infusion Preparation Room.
Medications found in the Infusion Preparation Room which the Department proved were not being held for destruction included, in relevant part, the following:
Approximately 20 unmarked pre-filled syringes containing Procrit stored in a plastic tray, approximately eight inches long, four inches wide, and two-thirds-inch high.
Procrit was, and still is, designated as a legend drug in Section 456.003(7), Florida Statutes (2001). Procrit is
indicated for very severe anemia, end-stage AIDS, hemorrhage, liver disease, or anti-viral medications that cause destruction of blood cells. Procrit needs to be stored refrigerated.
According to the manufacture's specifications, Procrit should be administered as soon as possible after it is drawn up to avoid issues of contamination. If properly stored, pre-filled syringes can be stored for up to two weeks;
Approximately the same number of unmarked pre-filled syringes containing Neupogen stored in another plastic tray identical to one in which the Procrit was found. Neupogen was, and still is, designated as a legend drug in Section 456.003(7), Florida Statutes (2001). Neupogen is indicated for patients undergoing chemotherapy or AIDS patients that have depressed immune systems. Neupogen needs to be stored refrigerated;
Two paper shopping-type bags labeled "Procrit" were stored on a shelf in the upper right cabinet in the room. These bags contained 200, unmarked pre-filled syringes. The syringes were filled with Serostim. Serostim was, and still is, designated as a legend drug in Section 456.003(7), Florida Statutes (2001). It is indicated for the treatment of AIDS wasting. In order to use it, it must be mixed with a dilutant and it should be stored in a refrigerator. Before dilution, Serostim may be stored at room temperature. Once diluted it should be used immediately; and
Novolin (insulin), stored in the manufacturer's box in the refrigerator.
There was no lot number, expiration date, or other identifying information on or with any of the pre-filled syringes found in the Infusion Preparation Room. The only identifying information concerning the pre-filled syringes consisted the name of the drug written on a piece of paper taped to the two trays in which the Procrit and Neupogen were stored. The pre-filled syringes of Serostim were not labeled in any way and, in fact, were stored in a bag with "Procrit" printed on it.
Dr. Wolland identified the pre-filled syringes of Procrit, Neupogen, and Serostim in her sworn written statement on November 29, 2001, and indicated that she pre-filled syringes with Procrit, Neupogen, and Serostim:
To prevent patients from selling injectable meds that they need, in particular, Serostim, Procrit, Neupogen, Decadurbolin, Depotestostorone & Rocaphin, I keep the injectables locked up in my cabinets and administer them to the patients as ordered, usually in pre-drawn syringes to prevent theft and resale. . . . I predraw these meds to avoid delay in administration time for pts who now must come in 5 days/week.
This ensures quick visits and guarantees the patients get their medicine administered correctly. The syringes are pre-filled and placed in trays in locked cabinets for quick and easy administration by staff to patients. These meds are stable to predraw syringes and retain potency. All pts on Serostim get the same does, 6mg/day. I have about 12 patients currently on Serostim, 30
does per pt per month. . . . Procrit has a tremendous street resale value, but only if it is in unopened vials - - can be sold on the street. By pre-drawing this and refrigerating it -- locked -- we prevent patients from [?] to take vials home & sell them. Instead they reliably get their weekly injection until they are no longer anemic & then it is stopped. On 11-29-01 I have about 20 pre-filled Procrit syringes. I have about 200 Serostim pre-filled syringes today. Neupogen . . . has a street resale value of over $1000 box for 10- unopened vials. Patients are tempted to
sell the Neupogen vials when I receive them. I have 20- pre-filled now. . . .
Dr. Wolland admitted that there were pre-filled syringes of Procrit and Neupogen found during the November 29, 2001, investigation during her testimony at hearing. She denied, however, that she knew about the pre-filled syringes of Serostim. In rejecting the admission in her sworn written statement that "I have about 200 Serostim pre-filled syringes today," Dr. Wolland testified that she was told to include that statement. Dr. Wolland's explanation is rejected. It is rejected because, not only did she make the statement under oath, she also told two different individuals, Inspector Lozowicki, and Ms. Ghabrial, that the pre-filled syringes in the Procrit bags contained Serostim.
Dr. Wolland has also asserted at hearing and in her post-hearing argument that the 200 pre-filled syringes of Serostim were proved, subsequent to November 29, 2001, to have
been filled by two then employees of Sunshine, Myra Williams- Wright and Sherry Farmer, who she testified intended to steal the medication. Dr. Wolland's testimony on this matter has not been credited. Her testimony in this regard was not based upon personal knowledge, but instead was based upon a Plea Agreement in the case of State of Florida v. Myra T. Williams-Wright, Case No. F02-3243, in the Circuit Court of the Eleventh Judicial Circuit in and for Miami-Dade County, Florida. That Plea Agreement does not support Dr. Wolland's speculation. First, although official recognition was taken of the Plea Agreement, which contains no reference to the 200 pre-filled syringes, and a transcript of an "Audiotaped Interview of Myra Williams-Wright Taken on February 1, 2002 by Investigators Thomas Vicente, Richard Bowden & Raymond Alamo," these pleadings are not part of the evidence of this proceeding. Having only taken official recognition of these documents, the only findings that can be made are that Ms. Williams-Wright entered a plea and that she gave a statement in a criminal proceeding which did not directly involve this matter. These are facts which are not relevant to this proceeding. Secondly, even if the contents of the pleadings are considered, they do not support Dr. Wolland's theory. The Plea Agreement makes no reference to Sunshine or the events of November 29, 2001. As to the transcript of
Ms. Williams-Wright's statement, while she does indicate that
she was involved in the theft of medications from Sunshine, including pre-filled syringes, no where in her statement does she make any reference to the pre-filled syringes found at Sunshine on November 29, 2001, and, in particular, the 200 pre- filled syringes which Dr. Wolland admitted knowledge of in her sworn statement and to two different people involved in the inspection contained Serostim.
While the Department proved the general manner in which the Procrit and Neupogen syringes were stored, it failed to prove clearly and convincingly where they were stored: on the shelf of the cabinets, as depicted in Petitioner's
Exhibit 3y; the counter-top under the cabinets as depicted in Petitioner's Exhibit 3z and 3aa; or in the refrigerator, as testified to by Dr. Wolland.13
As to the Serostim, they were stored on the top shelf of one of the cabinets in the Infusion Preparation Room and were not refrigerated. Dr. Wolland's testimony to the contrary is rejected as lacking credibility.
As to the Novolin, although it was stored in the refrigerator, unexpired and expired boxes were stored together.
The Department failed to prove that Dr. Wolland's improper storage of Procrit, Neupogen, Serostim or Novolin constituted "[p]rescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a
legend drug, including all controlled substances, other than in the course of the osteopathic physician's professional
practice." (Emphasis added). The evidence proved that all of the medicines were maintained in the course of Dr. Wolland's practice.
While Dr. Wolland testified at hearing that she only pre-filled enough syringes to meet the needs of the patients she saw in a day, the number of syringes pre-filled with Procrit, Neupogen, and Serostim found in the Infusion Preparation Room exceeded the number of patients which could reasonably be expected to need those drugs on November 29, 2001.
The Medication Storage Laboratory.
The Medication Storage Laboratory was locked when the inspection began and was opened to allow the inspection team to enter.
A refrigerator, approximately 12 to 15 cubic feet, was used to store medications, in large part vaccinations used primarily for children, in the Medication Storage Laboratory. Insulin was also stored in this refrigerator. There was no locking mechanism on the refrigerator.
On November 29, 2001, the refrigerator was found to contain, among other things, several plastic trays containing pre-filled, unlabeled syringes. Petitioner's Exhibit 3d is an
accurate depiction of the contents of the refrigerator at the time it was first opened on November 29, 2001.
In addition to the medications found in the refrigerator, there was a large plastic bottle of Zephyrhills water.
The trays themselves containing the pre-filled syringes which were found in the refrigerator had paper labels attached to them. The type of medication the syringes contained had been written on those labels. There was no other identifying information on the paper labels or the syringes, such as when the syringes were drawn, the expiration date of the medication, the medication "lot number," or who the syringes were intended for.
The syringes themselves were, to the extent visible in Petitioner's Exhibit 3b, identical and indistinguishable. Therefore, if one syringe meant for one tray was incorrectly placed in another tray, which in a practice as large as
Dr. Wolland's was highly probable, there would be no way of knowing.
One tray, labeled as "DTAP," contained a clear liquid in which some of the syringes were sitting. This tray was located below the spout of the Zephyrhills water bottle. While there was a blueish-green substance floating in the liquid and one of the syringes appeared to have a foreign substance of a
green/gray color inside it, the evidence failed to prove what these substances were. The evidence also failed to prove what the liquid was.14
It could not be accurately determined from any information kept with the syringes or the trays when the pre- filled syringes found in the refrigerator were filled. Even Dr. Wolland admitted that they could have been filled the day before or even two days before November 29, 2001.
Dr. Wolland's testimony concerning the pre-filled syringes, in particular, how they could be identified by her or anyone else who used those syringes, has not been credited. While she gave testimony as to how a pre-filled syringe might be identified, she was unable to explain how the pre-filled syringes found in the refrigerator were actually identifiable. Even her explanation of how pre-filled syringes might be identified was inconsistent. At one point, she gave the following explanation of how the contents of the trays of pre- filled syringes found in the refrigerator might have been identified:
Q. Let me ask you this. Commonly, before November 29, 2001, those baskets that are in this refrigerator, are the contents labeled at all, the contents themselves?
A. Yes.
Q. How?
A. They're labeled, should have a sticker, each syringe, saying the type of medication in it. And within the basket should be the vial they're drawn from, to ascertain the lot number, because every vaccine that is administered has a lot number in both the patient's chart and the vaccine log, it's a must, every shot has to have a lot number, it must and it does. [Emphasis added].
Transcript, page 696, lines 10-21. On further inquiry, she testified as follows:
Q. The vaccines that were in the refrigerator, you're saying that each vaccine that was in a syringe should have a label on it. Is that correct?
A. It should have a label on it, or it should -- it should -- for example, like the DPT tray should have, that DPT tray should not be just syringes containing probably the DPT, they should have the box of DPT with the vial, and should fill up a syringe, give it to the patient, or there could be three or four syringes in there for the morning, which in that case, as long as it's with the log and the vial it came from, because the lot number must be identified, that should be sufficient. . . .
. . . .
Q. According to you, the individual syringes that are located in the refrigerator should be labeled. Is that correct?
A. They could be labeled. If they are with the bottle that it's drawn from taken from the bottle, with its bottle, I don't know that is necessary. I don't think there is a law that says that is necessary.
Transcript, page 698, lines 15-25, and page 699, lines
1-3 and 9-15.
More importantly, the evidence proved that Dr. Wolland had failed to use any appropriate method of identifying the individual pre-filled syringes found on November 29, 2001, in the refrigerator in the Medication Storage Laboratory.
The refrigerator also contained expired and unexpired manufactures boxes of Novolin (insulin). Why Dr. Wolland maintained expired insulin was not explained.
There were also cabinets in the Medication Storage Laboratory. Unlike the Infusion Preparation Room, these cabinets were not locked. There was also no area of the cabinets designating the contents as being held for destruction. What was contained in the cabinets was not proved by the Department.
The Department failed to prove that Dr. Wolland's improper storage of the pre-filled syringes and the Novolin in the Medication Storage Laboratory constituted "[p]rescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including all controlled substances, other than in the course of the osteopathic physician's professional practice." (Emphasis added). The evidence proved that all of the medicines were maintained in the course of Dr. Wolland's practice.
Dr. Wolland's Use of Pre-filled Syringes and Adulterated and Expired Medications Dispensed to Other Patients.
In her sworn, written statement, in statements to investigators, and at hearing Dr. Wolland admitted that she administered or had her staff administer pre-filled syringes to patients. Her written statement on this matter is quoted in paragraph 59.
Dr. Wolland also admitted to Investigator Lozowicki that Adulterated and Expired medications, which she admitted her patients had given to her for destruction, were sometimes given to other patients "who may have run out or need a few for a few days." Although Dr. Wolland denied at hearing that she ever used medications in this manner and denied making such an admission to Investigator Lozowicki, her testimony has not been credited. Inspector Lozowicki's testimony has been accepted as credible, in large part because she memorialized Dr. Wolland's admission in a Memorandum to the MFCU Bureau Chief the day after the inspection:
She said that she requested from her patients that they bring to her the medications that the patient is no longer taking so they won't get confused with the other medications they are currently taking. She uses these drugs to give to other patients who may have run out or need a few for a few days.
The Standard of Care.
Joel Rose, D.O., was accepted as an expert in the field of osteopathic medicine.
Dr. Rose, who is board certified by the American Osteopathic Board of Family Physicians, has been a licensed osteopathic family physician in Florida since July 1984.
Dr. Rose described his current practice as follows:
I have a solo private practice in Tampa, Florida. I treat patients, mostly adolescent through senior years, with all varieties of conditions within the scope of family medicine.
Transcript, page 443, lines 16-19.
As for his treatment of HIV positive patients,
Dr. Rose indicated the following in response to a question as to whether HIV positive patients were the primary scope of his
work:
No, it's probably the minority scope, because the practice is not dedicated to that exclusively, but there in our area there's very few primary care physicians who will handle an immunocompromised patient, and less of them every day.
Transcript, page 443, lines 22-25, and page 444, line 1.
Dr. Rose, "at different points in [his] practice" has prescribed "Procrit, Neupogen, Deca-Durabolin, Serostim, [and] Novolin."
Dr. Rose's practice is very dissimilar from Dr.
Wolland's practice on November 29, 2001. Depending on the issue, it might even be concluded that he is not "a reasonably prudent similar osteopathic physician." As to the issues in this case, however, which involve only the proper storage and use of medications, Dr. Rose qualified to opine on "the level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances" and his opinions, which were unrebutted, have been credited.
Dr. Wolland improperly stored pre-filled syringes and expired Novolin, as found, supra. While her improper storage of may by itself constitute a violation of the standard of care imposed on osteopathic physicians, no such charge has been made in the Administrative Complaint.
Instead, the Administrative Complaint charges that she violated the standard of care by injecting "improperly stored medications into patients." Dr. Wolland admitted that, while she had not yet done so, she intended to use the improperly labeled and stored pre-filled syringes on her patients and that she had used such pre-filled syringes stored in such manner as pre-filled syringes were found on November 29, 2001, on her patients. She has, therefore, violated the standard of care by
injecting unlabeled and improperly stored medications into patients.
Dr. Wolland also violated the standard of care by administering "medications to patients from other patient's open pharmacy purchased bottles."
Finally, the evidence failed to prove that Dr. Wolland violated the standard of care by keeping "large quantities of expired medications in her office stored with medication that had not expired." While she commingled expired and unexpired Novolin, Dr. Rose did not offer an opinion as to the inappropriateness of Dr. Wolland's storage of Novolin.
CONCLUSIONS OF LAW
Jurisdiction.
The Division of Administrative Hearings has jurisdiction over the subject matter of this proceeding and of the parties thereto pursuant to Sections 120.569 and 120.57(1), Florida Statutes (2005).
The Charges of the Administrative Complaint.
The grounds which may support the Department's assertion that Dr. Wolland's license should be disciplined are limited to those specifically alleged in the Administrative Complaint. See, e.g., Cottrill v. Department of Insurance, 685 So. 2d 1371 (Fla. 1st DCA 1996); Kinney v. Department of State,
501 So. 2d 129 (Fla. 5th DCA 1987); and Hunter v. Department of Professional Regulation, 458 So. 2d 842 (Fla. 2d DCA 1984).
Section 459.015(2), Florida Statutes (2001), authorizes the Board of Osteopathic Medicine (hereinafter referred to as the "Board"), to impose the penalties specified in Section 456.072(2), Florida Statutes, which range from the issuance of a letter of concern to revocation of a physician's license to practice osteopathic medicine in Florida, if a physician commits one or more of the acts specified in Section 459.015(1), Florida Statutes (2001).
In Count One of its Administrative Complaint, the Department has alleged that Dr. Wolland violated Section 459.015(1)(t), Florida Statutes (2001), which provides that the following acts constitute grounds for disciplinary action by the
Board:
Prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing a legend drug, including all controlled substances, other than in the course of the osteopathic physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the osteopathic physician's professional practice, without regard to his or her intent.
In Count Two of the Administrative Complaint, the Department has alleged that Dr. Wolland violated Section 459.015(1)(x), Florida Statutes (2001), which provides that the following act constitutes grounds for disciplinary action by the Board:
Gross or repeated malpractice or the failure to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar osteopathic physician as being acceptable under similar conditions and circumstances. . . .
[Emphasis added].
The Burden and Standard of Proof.
The Department seeks to impose penalties against Dr. Wolland through the Administrative Complaint that include
suspension or revocation of her license and/or the imposition of an administrative fine. Therefore, the Department has the burden of proving the specific allegations of fact that support its charge that Dr. Wolland violated Section 459.015(1)(t) and (x), Florida Statutes, by clear and convincing evidence.
Department of Banking and Finance, Division of Securities and
Investor Protection v. Osborne Stern and Co., | 670 | So. 2d 932 |
(Fla. 1996); Ferris v. Turlington, 510 So. 2d | 292 | (Fla. 1987); |
Pou v. Department of Insurance and Treasurer, | 707 | So. 2d 941 |
(Fla. 3d DCA 1998); and Section 120.57(1)(j), Florida Statutes (2005)("Findings of fact shall be based on a preponderance of
the evidence, except in penal or licensure disciplinary proceedings or except as otherwise provided by statute.").
What constitutes "clear and convincing" evidence was described by the court in Evans Packing Co. v. Department of Agriculture and Consumer Services, 550 So. 2d 112, 116, n. 5 (Fla. 1st DCA 1989), as follows:
. . . [C]lear and convincing evidence requires that the evidence must be found to be credible; the facts to which the witnesses testify must be distinctly remembered; the evidence must be precise and explicit and the witnesses must be lacking in confusion as to the facts in issue. The evidence must be of such weight that it produces in the mind of the trier of fact the firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.
Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).
See also In re Graziano, 696 So. 2d 744 (Fla. 1997); In re
Davey, 645 So. 2d 398 (Fla. 1994); and Walker v. Florida Department of Business and Professional Regulation, 705 So. 2d 652 (Fla. 5th DCA 1998)(Sharp, J., dissenting).
The Alleged Violation of Section 459.015(1)(t), Florida
Statutes (2001).
The Department has alleged that Dr. Wolland committed a violation of Section 459.015(1)(t), Florida Statutes (2001), in one or more of the following ways:
She inappropriately stored legend drugs.
She inappropriately injected and administered unlabeled and improperly stored medication.
While these factual allegations were proved generally, Dr. Wolland's inappropriate storage and use of medications was not proved to be a violation of Section 459.015(1)(t), Florida Statutes (2001), because the inappropriately stored pre-filled syringes found at Sunshine on November 29, 2001, were being stored "in the course of the osteopathic physician's professional practice."
While Section 459.015(1)(t), Florida Statutes (2001), provides a presumption that improperly "prescribing, dispensing, administering, supplying, selling, giving, mixing, or otherwise preparing legend drugs, including all controlled substances, inappropriately . . . is not in the best interest of the patient and is not in the course of the osteopathic physician's professional practice," it is concluded that that presumption was overcome in this case.
It is, therefore, concluded that the Department has failed to prove that Dr. Wolland violated Section 459.015(1)(t), Florida Statutes (2001).
The Alleged Violation of Section 459.015(1)(x), Florida Statutes (2001).
The Department has alleged that Dr. Wolland committed a violation of Section 459.015(1)(x), Florida Statutes (2001), in one or more of the following ways:
She injected unlabeled, adulterated and improperly stored medication into patients.
She kept large quantities of expired medication in her office stored with medication that had not expired.
She administered medications to patient from other patient's open pharmacy purchased bottles.
The evidence proved clearly and convincingly that Dr. Wolland violated the standard of care by her use of unlabeled and improperly stored pre-filled syringes to inject patients and by administering "medications to patients from other patient's open pharmacy purchased bottles."
It is, therefore, concluded that the Department has proved that Dr. Wolland violated Section 459.015(1)(x), Florida Statutes (2001).
The Appropriate Penalty
In determining the appropriate punitive action to recommend to the Board in these cases, it is necessary to consult the Board's "disciplinary guidelines," which impose restrictions and limitations on the exercise of the Board's
disciplinary authority. See Parrot Heads, Inc. v. Department of Business and Professional Regulation, 741 So. 2d 1231 (Fla. 5th DCA 1999).
The Board's guidelines are set out in Florida Administrative Code Rule 64B15-19.002, which provides the following instruction on the application of the penalty ranges provided in the Rule:
In imposing discipline upon applicants and licensees, the board shall act in accordance with the following disciplinary guidelines and shall impose a penalty within the range corresponding to the violations set forth below. The statutory language is intended to provide a description of the violation and is not a complete statement of the violation; the complete statement may be found in the statutory provision cited directly under each violation description.
Florida Administrative Code Rule 64B15-19.002(31), goes on to provide, in pertinent part, for a minimum penalty of a probation and a $5,000.00 fine and a maximum penalty of a suspension followed by a probation and a $7,500.00 fine for a violation of Section 459.015(1)(t), Florida Statutes (2001); and a minimum penalty of probation and a $7,500.00 fine and a maximum penalty of revocation and a $10,000 fine for a violation of Section 459.015(1)(x), Florida Statutes (2001).
Greater penalties are specified for second offenses.
Although this case involves the second Administrative Complaint tried before the Division of Administrative Hearings, the
offenses at issue in this case are all first-time offenses of the statutory provisions at issue.
Florida Administrative Code Rule 64B15-19.003, provides that, in determining the appropriate penalty, the following aggravating and mitigating circumstances are to be taken into account in determining the penalty:
The danger to the public;
The length of time since the violations;
The number of times the licensee has been previously disciplined by the Board;
The length of time the licensee has practiced;
The actual damage, physical or otherwise, caused by the violation;
The deterrent effect of the penalty imposed;
The effect of penalty upon the licensee’s livelihood;
Any effort of rehabilitation by the licensee;
The actual knowledge of the licensee pertaining to the violation;
Attempts by the licensee to correct or stop violations or refusal by licensee to correct or stop violations;
Related violations against licensee in another state, including findings of guilt or innocence, penalties imposed and penalties served;
The actual negligence of the licensee pertaining to any violations;
The penalties imposed for related offenses;
The pecuniary gain to the licensee;
Any other relevant mitigating or aggravating factors under the circumstances. Any penalties imposed by the board may not exceed the maximum penalties set forth in Section 459.015(2), F.S.
In its Proposed Recommended Order, the Department has recommended that Dr. Wolland's license be revoked based in part upon the fact that discipline has been recommended in DOAH Case No. 05-0860PL, "the danger to the public based upon Respondent's violation of the standard of care, and the general deterrent that a harsh penalty would result in "
Having carefully considered the facts of this matter in light of the provisions of Florida Administrative Code Rule 64B15-19.003, it is concluded that the Department's suggested penalty is excessive. The Department's suggested penalty fails to take into account the following factors:
The evidence failed to prove that there was any actual damage or harm, physical or otherwise, caused by Dr. Wolland's actions;
Her license and, consequently, her ability to freely practice has been restricted for almost two and one-half years; and
She has already taken steps to better educate herself about the proper method of medication storage by taking a continuing education course of medication storage.
The Department's suggested penalty is also rejected because it was based, in part, upon the erroneous assumption that it had proved both Counts of the Administrative Complaint and that all the factual bases for those Counts were proved.
Based upon the foregoing, it would be appropriate to suspend Dr. Wolland's license for two years, followed by probation for a period of three years and she should be required to pay a fine in the amount of $10,000.00.
Based on the foregoing Findings of Fact and Conclusions of Law, it is
RECOMMENDED that the a final order be entered by the Board of Osteopathic Medicine: dismissing Count One of the Administrative Complaint; finding that Shelly O. Wolland, D. O., has violated Section 456.072(1)(x), Florida Statutes, as described in this Recommended Order; requiring that she pay a fine in the amount of $10,000.00; suspending her license for a period of two years followed by three years of probation; and requiring that she complete continuing education in medication storage as directed by the Board of Osteopathic Medicine.
DONE AND ENTERED this 12th day of October, 2005, in Tallahassee, Leon County, Florida.
S
LARRY J. SARTIN
Administrative 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 Administrative Hearings this 12th day of October, 2005.
ENDNOTES
1/ In argument raised primarily in another case in which Dr. Wolland was Respondent then pending before the Division of Administrative Hearings, DOAH Case No. 05-0860PL, and to a lesser extent in this case, it was suggested by Dr. Wolland that Petitioner has wrongly withheld her request for a formal hearing in this matter. It was also argued, again primarily in the other case, that an emergency order of restriction of Dr.
Wolland's license had been issued as a result of the facts alleged in this case. The evidence presented in this case, however, failed to prove why it took almost three years for Dr. Wolland's request for a formal administrative hearing to be filed with the Division of Administrative Hearings. As to the emergency order, while proof concerning the order was presented in DOAH Case No. 05-0860PL, no such proof was offered in this case.
Dr. Wolland, in her Proposed Recommended Order has suggested that a motion to dismiss this proceeding due the untimeliness of the referral of her request for hearing had been made by her.
While Dr. Wolland did file such a motion in DOAH Case No. 05- 0860PL, which was denied, no such motion has been filed in this case.
2/ A Recommended Order was entered in DOAH Case No. 05-0860PL.
3/ Counsel for Dr. Wolland represented that the composite exhibit consisted of a "Plea Agreement of Myra Williams Wright - and Her Annexed Statement to Medicaid Fraud Investigators Thomas Vicente, Richard Bowden and Raymond Alamo." The Plea Agreement and statement were represented to be from the official court records in the case of State of Florida v. Myra T. Williams- Wright, Case No. F02-3243, in the Circuit Court of the Eleventh Judicial Circuit in and for Miami-Dade County, Florida.
4/ The copy of Respondent's composite exhibit 1 for which official recognition had been requested at hearing was not certified by the clerk of the circuit court.
5/ Although filed one day late, Petitioner did not gain an advantage and, therefore, its proposed order has been fully considered.
6/ There were other individuals, not relevant to this matter, involved during the investigation not mentioned in this Recommended Order.
7/ Inspector Schue's choice, in some cases, of the label he
placed on a room does not necessarily accurately describe the functions to which the room was intended or actually used. In particular, his labels for the two most significant areas of the offices of Sunshine, the Infusion Preparation Room and the Medical Storage Laboratory, are not accurate descriptions of the actual uses of those rooms. Nonetheless, his labels do establish, to the extent relevant, an accurate geographic reference to where medications were located which was utilized throughout the hearing.
8/ Respondent has suggested in her Proposed Recommended Order that she had been informed that the inspection would take place on November 29, 2001. She did, however, clearly and convincingly testified to this alleged fact. The only other evidence on this point is a statement made by Investigator Lozowicki in an Investigative Note she wrote on or about November 17, 2001: "On November 26, 2001, this investigator personally deliver to Maria Vega, Office Manager, a letter informing Dr. Wolland of the scheduled inspection allowing her and her staff 72 hours to prepare for the inspection." This statement can be interpreted to mean that Dr. Wolland was told of the exact date or that 72 hours passed from the time she was
informed that an inspection would occur on some unspecified date and November 29, 2001. Consequently, it is concluded that the credible evidence presented in this case failed to prove that Dr. Wolland was informed on the actual date of the inspection.
9/ Dr. Wolland did not, as alleged in paragraph 8 of the Administrative Complaint, request that her patients bring her their unused medication to her.
10/ When asked about a green paper attached to the inside of a cabinet door which is visible in Petitioner's Exhibit 3k,
Dr. Wolland merely stated "That could be the sign that says quarantined, hold for destruction." Transcript, page 646, lines 5-6. If there indeed was such a sign, Dr. Wolland should have known where it was located, which she obviously did not. Dr.
Wolland also testified that she kept a log of medications meant for destruction, but she failed to offer the log or explain what had happened to it.
11/ Dr. Wolland also testified, unconvincingly, that a log of medications held for destruction was maintained by her. That log, however, was not produced at hearing.
12/ Any testimony that there were no locking mechanisms on the cabinets and/or the refrigerator in the Infusion Preparation Room would be rejected as lacking credibility.
13/ While the photographs admitted as Petitioner's Exhibit 3 depict them in the cabinets and on the counter, Ms. Ghabrial testified that they were found in a refrigerator.
14/ The Department suggested that the liquid in which the syringes labeled DTAP were found was water from the freezer located in the top of the refrigerator. This suggestion is too speculative to clearly and convincingly prove what the liquid was or where it came from.
COPIES FURNISHED:
Ellen M. Simon Kurt L. Barch
Assistants General Counsel Prosecution Services Unit Office of the General Counsel Department of Health
4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265
Diane K. Kiesling
Attorney Supervisor, Litigation Office of the General Counsel Department of Health Prosecution Services Unit
4052 Bald Cypress Way, Bin C65 Tallahassee, Florida 32399-3265
Joseph s. Paglino, Esquire
Law Offices of Joseph S. Paglino 12865 West Dixie Highway
North Miami, Florida 33161
Pamela King, Executive Director Board of Osteopathic Medicine Department of Health
4052 Bald Cypress Way, Bin C06 Tallahassee, Florida 32399-1701
Dr. John O. Agwunobi, Secretary Department of Health
4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
Timothy M. Cerio, General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
R.S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 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 these cases.
| Issue Date | Document | Summary |
|---|---|---|
| Oct. 27, 2006 | Mandate | |
| Dec. 22, 2005 | Agency Final Order | |
| Oct. 12, 2005 | Recommended Order | Respondent`s improper storage of pre-filled syringes and dispensing of medicine of one patient to another violated the standard of care. |
