Respondent's Exhibits 1 through 32 were admitted.
The final hearing Transcript was filed on April 18, 2013. The Department and Dr. Lior timely filed proposed recommended orders, which were considered in preparing this Recommended Order. Dr. Lior also filed a Closing Argument which has been considered.
Unless otherwise indicated, all rule and statutory references are to the versions in effect at the time of the alleged violation.
At all times relevant to this case, Dr. Lior, M.D., was licensed to practice medicine in the State of Florida, having been issued license number ME 74061, and was board-certified by the American Board of Dermatology.
The Department has regulatory jurisdiction over licensed physicians such as Dr. Lior. In particular, the Department is authorized to file and prosecute an administrative complaint against a physician, as it has done in this instance, when a panel of the Board of Medicine has found that probable cause exists to suspect that the physician has committed a disciplinable offense.
Here, the Department alleges that Dr. Lior committed one such offense. In the one-count Complaint, the Department charges that Dr. Lior violated section 456.072(1)(bb), "by performing or attempting to perform health care services on the wrong patient,
a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition."
Dr. Akhtar's Examination
On January 11, 2010, Patient S.L., a 74-year-old gentleman, presented to Asfa Akhtar, D.O., a general dermatologist employed by the Cleveland Clinic Florida, for an evaluation of a lesion inside his left ear. It was noted on that date that S.L. had a positive history for skin cancer.
Dr. Akhtar performed a physical examination of S.L., and his contemporaneous note provides, in pertinent part, as follows: "Exam of the face, ears and hands reveal a pearly papule with rolled borders on the right helix."1/ On that date Dr. Akhtar's assessment included "R/O BCC-right helix." In other words,
Dr. Akhtar wanted to rule out basal cell carcinoma on S.L.'s right helix.
Dr. Akhtar's plan was to conduct a "shave biopsy." Prior to performing the biopsy, the location was marked with a pen and photographed. Dr. Akhtar then performed the biopsy by scraping skin cells of the surface skin of the suspicious area. The subsequent surgical pathology report provides, in pertinent part, as follows:
Final Pathologic Diagnosis SKIN BIOPSY, RIGHT HELIX:
In correspondence dated January 20, 2010, Dr. Akhtar advised S.L. that the pathologic findings from the biopsy specimen of S.L.'s right helix confirmed a basal cell carcinoma. Dr. Akhtar recommended that it "be treated by a technique called Mohs Surgery to be certain as possible that it is completely removed."
January 26, 2010 Consultation
On January 26, 2010, S.L. presented to Dr. Lior for a Mohs surgical consultation. In addition to being board-certified in dermatology, Dr. Lior is qualified as a Mohs surgeon. On that date, Dr. Lior, who is also employed at the Cleveland Clinic, had access to the records of Dr. Aktar's office visit, the biopsy photograph, and the pathology report. Additionally, Dr. Lior's nurse, Diane Donner, LPN, obtained additional history from the patient. Specifically, Ms. Donner noted that, "[p]atient states he has surgery in the area approximately 3 years ago. It has been present for 3 YEAR(S)."
Dr. Lior then performed an examination of S.L.'s right helix; however, her examination did not include the entire right helix. Specifically, Dr. Lior did not examine the top of the
helix of S.L.'s ear. Instead, Dr. Lior conducted a "focused examination" on an observed scarred pearly papule on the helix of the right ear just superior to (above) the mid-line of the ear.
Dr. Lior explained the methodology utilized in limiting her examination to a specific location on the helix, as follows:
Q. . . . What information from those records would indicate where on that right helix that you just described that either the biopsy was taken or that there was biopsy- proven carcinoma?
A. Right. So when we get that information, patient participation is expected. We ask the patient. We get a history. Then we also need to look at the area and see what looks consistent with the biopsy site as well. And so all of these things, when you actually see a cancer and you see a scar and you see the skin graft area, and the patient tells you that that's the site, you put it together with your biopsy pathology report, as well as your office notes. It's what we use all together.
Based on Dr. Lior's experience, the observed papule was consistent with the clinical appearance of basal cell carcinoma. Dr. Lior credibly testified that S.L. pointed to the same area she was palpating and advised her that he had previously undergone Mohs surgery and that the cancer had returned.
Dr. Lior discussed treatment options with S.L. and advised that Mohs surgery would be appropriate, to which S.L. agreed. Dr. Lior's record of the consultation provides in pertinent part, as follows:
Physical Exam: Right superior helix: There is a 1 cm scarred, crusted, pearly papule.
Impression: Biopsy-proven basal cell carcinoma. Patient notes this is recurrent.
Plan: Therefore indicated for Mohs surgery.
February 11, 2010 Mohs Surgery
S.L. returned to Dr. Lior for the scheduled Mohs surgery on February 11, 2010. Upon entering the surgical room,
S.L. was engaged in a conversation with Ms. Donner concerning the location of the site. Dr. Lior greeted and approached S.L., obtained the prior photograph, approached S.L.'s ear, and stated, "let's take a look."
As she was attempting to match the photograph with the area of the ear, S.L. stated to Dr. Lior, "Don't you see the scar?" while simultaneously pointing to the location of the scar tissue.
Dr. Lior indeed observed the scar tissue from the prior skin graft and again, like the January 26, 2010, consultation, noted the area was consistent with recurrent basal cell carcinoma. The location was noted to be just above the scar. Dr. Lior proceeded to palpate or touch the suspicious area.
Thereafter, Dr. Lior proceeded to mark the intended surgical location on S.L.'s ear with a marker pen. Subsequently, a photograph of the marked location was obtained, the patient's informed consent was obtained, and an informed consent document
was executed by S.L. A time-out was then performed where Dr. Lior and her assistant agreed upon the procedure and location.
The surgical site was then sterilized and injected with lidocaine. At no time prior to the surgery did S.L. voice any concerns or objections related to the proposed surgical site.
S.L. was not, however, provided a mirror to examine the proposed marked location. Additionally, there was no evidence that S.L. was shown a copy of the photograph obtained by Dr. Lior prior to surgery.
Dr. Lior then proceeded to perform the Mohs surgery without incident. After completing the procedure, S.L.'s ear was bandaged and S.L. waited in a separate room while the excised portion of the ear was examined to determine whether there were "clear margins"--the absence of basal cell carcinoma.
After completing the examination, Dr. Lior requested that S.L. return to the operating area to discuss the findings. When S.L. returned, Dr. Lior stated, "Good news, it's all clear, the margins are clear, there's no cancer, we're going to repair the area." In response, S.L. replied that, "[t]he site was not here, it was here." S.L. then bent the top of his ear down, and Dr. Lior observed--for the first time--a papule consistent with basal cell carcinoma.2/
It is undisputed that this newly-observed papule was the site of biopsy-proven basal cell carcinoma. Dr. Lior conceded that it was her plan, at the conclusion of the
January 26, 2010, consultation, to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. She further conceded that, on February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix different from the location that was the subject of the biopsy performed by
Dr. Akhtar.3/
Dr. Lior offered to perform a Mohs surgery on the newly-observed/previously-biopsied location; however, S.L. elected to defer the procedure for a later date. Accordingly, Dr. Lior closed the existing excision site and performed a skin graft in the area.
Dr. Lior provided S.L. with her contact information and informed S.L. that she would attempt to arrange for the Cleveland Clinic to withhold the charges for the surgical procedure performed. The Cleveland Clinic reversed the charges, as requested.
S.L. declined to return to the Cleveland Clinic for suture removal or for any additional procedures.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has personal and subject matter jurisdiction in this proceeding pursuant to sections 120.569, and 120.57(1), Florida Statutes.
A proceeding, such as this one, to suspend, revoke, or impose other discipline upon a license is penal in nature. State ex rel. Vining v. Fla. Real Estate Comm'n, 281 So. 2d 487, 491 (Fla. 1973). Accordingly, to impose discipline, the Department must prove the charges against Dr. Lior by clear and convincing evidence. Dep't of Banking & Fin., Div. of Sec. & Investor Prot.
v. Osborne Stern & Co., 670 So. 2d 932, 933-34 (Fla. 1996)(citing Ferris v. Turlington, 510 So. 2d 292, 294-95 (Fla. 1987)); Nair
v. Dep't of Bus. & Prof'l Reg., Bd. of Med., 654 So. 2d 205, 207 (Fla. 1st DCA 1995).
Regarding the standard of proof, in Slomowitz v.
Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983), the Court developed a "workable definition of clear and convincing evidence" and found that of necessity such a definition would need to contain "both qualitative and quantitative standards." The Court held that:
[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 testimony must be precise and explicit and the witnesses must be lacking 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 a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.
Id. The Florida Supreme Court later adopted the Slomowitz
court's description of clear and convincing evidence. See In re
Davey, 645 So. 2d 398, 404 (Fla. 1994). The First District Court of Appeal also has followed the Slomowitz test, adding the interpretive comment that "[a]lthough this standard of proof may be met where the evidence is in conflict . . . it seems to preclude evidence that is ambiguous." Westinghouse Elec. Corp. v. Shuler Bros., Inc., 590 So. 2d 986, 988 (Fla. 1st DCA 1991); rev. denied, 599 So. 2d 1279 (Fla. 1992)(citations omitted).
In the Complaint, the Department charged Dr. Lior under section 456.072(1)(bb), which provides, in pertinent part, as
follows:
(1) The following acts shall constitute grounds for which disciplinary actions specified in subsection (2) may be taken:
* * *
(bb) Performing or attempting to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient's diagnosis or medical condition.
Id. (emphasis added).
Being penal in nature, the foregoing statutory provision "must be construed strictly, in favor of the one against whom the penalty would be imposed." Munch v. Dep't of
Prof'l Reg., Div. of Real Estate, 592 So. 2d 1136, 1143 (Fla. 1st DCA 1992).
Dr. Lior concedes, as she must, that she performed Mohs surgery on a location different than the location that was the subject of the biopsy performed by Dr. Akhtar. Dr. Lior contends, however, that she is not subject to discipline under section 456.072(1)(bb), as she performed her surgical procedure at the location of a pearly papule that was clinically consistent with basal cell carcinoma, on the right superior helix just above the midline of the ear, and at the same location that she had identified as the area of intended surgery at the consultation visit on January 26, 2010. In other words, although the surgical location was not the site of Dr. Akhtar's biopsy, it was not a "wrong-site" as she performed surgery at the exact location that she had identified as the area for the surgical procedure at the time of the consultation visit and on the day of surgery.
In an effort to enforce this position, Dr. Lior relies upon three administrative orders. The first is Department of
Health v. Dietrick, M.D., Case No. 05-2796 (Fla. DOAH Nov. 21, 2005), accepting exception to conclusion of law that it was unnecessary to address applicability of section 766.103, Florida
Statues, Case No. 2003-12350 (Fla.DOH Feb. 16, 2006). In Dietrick, the physician was determined not to have performed a wrong-site surgery. In contrast to the instant facts, the physician, after conducting a physical examination, secured the patient's informed consent to perform a procedure that was different from that originally planned.
The second, Department of Health v. Diaz-Ramirez, M.D., Case No. 10-9316 (Fla. DOAH Feb. 16, 2011; Fla. DOH Apr. 12, 2011), is similarly distinguishable as the patient was advised that a procedure different from that originally scheduled would be performed, and the patient consented to the new procedure. Finally, Department of Health v. Sharma, M.D., Case No. 10-2416 (Fla. DOAH Feb. 16, 2011; Fla. DOH Apr. 12, 2011), lends no support to Dr. Lior's position as the physician deliberately changed the scheduled procedure based on the patient's symptoms and the patient consented to the same.
Though artfully framed, Dr. Lior's argument is ultimately unsuccessful. Dr. Akhtar referred S.L. to Dr. Lior for a Mohs consultation for removal of the basal cell carcinoma established by biopsy on S.L.'s right helix. Dr. Lior conceded that it was her plan to perform a Mohs surgery on the site of the biopsy-proven basal cell carcinoma. On February 11, 2010, she performed the Mohs surgery on a location of S.L.'s right helix
different from the location that was the subject of the biopsy performed by Dr. Akhtar.
Given the totality of the circumstances, Dr. Lior's identification of the intended surgical site was reasonable. Nevertheless, the undersigned concludes that the surgery was performed at the wrong-site. Thus, the Department has proven by clear and convincing evidence that Dr. Lior violated
section 456.072(1)(bb).
The Board of Medicine imposes penalties upon licensees in accordance with the disciplinary guidelines prescribed in Florida Administrative Code Rule 64B8-8.001. The range of penalties for a first offense involving section 456.072(1)(bb) is set forth in rule 64B8-8.001(2)(ss). The range is set forth as follows:
From a $1,000.00 fine, a letter of concern, a minimum of five hours of risk management education and one hour lecture on wrong-site surgery in the State of Florida to a
$10,000.00 fine, a letter of concern, a minimum of five hours of risk management education, 50 to 100 hours of community service, undergo a risk management assessment, a one hour lecture on wrong-site surgery, and suspension to be followed by a term of probation.
Rule 64B8-8.001(3) provides that, in applying the penalty guidelines, the following aggravating and mitigating circumstances shall be considered:
Exposure of patient or public to injury or potential injury, physical or otherwise: none, slight, severe, or death;
Legal status at the time of the offense: no restraints, or legal constraints;
The number of counts or separate offenses established;
The number of times the same offense or offenses have previously been committed by the licensee or applicant;
The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice;
Pecuniary benefit or self-gain inuring to the applicant or licensee;
The involvement in any violation of Section 458.331, F.S., of the provision of controlled substances for trade, barter or sale, by a licensee. In such cases, the Board will deviate from the penalties recommended above and impose suspension or revocation of licensure.
Where a licensee has been charged with violating the standard of care pursuant to Section 458.331(1)(t), F.S., but the licensee, who is also the records owner pursuant to Section 456.057(1), F.S., fails to keep and/or produce the medical records.
Any other relevant mitigating factors.
Having considered the potential aggravating and mitigating factors, the undersigned does not find compelling reasons to deviate from the guidelines and, therefore, recommends that the Board of Medicine impose a penalty that falls within the
