STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
DEPARTMENT OF HEALTH, BOARD OF MEDICINE,
Petitioner,
vs.
CESAR AUGUSTO VELILLA, M.D.,
Respondent.
/
Case No. 15-4397PL
RECOMMENDED ORDER
On March 30, 2016, final hearing was held at video teleconference locations in Lauderdale Lakes and Tallahassee, Florida, before F. Scott Boyd, an Administrative Law Judge assigned by the Division of Administrative Hearings.
APPEARANCES
For Petitioner: Zachary Bell, Esquire
Yolonda Y. Green, Esquire Department of Health Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Bruce Douglas Lamb, Esquire
Gunster, Yoakley and Stewart, P.A.
401 East Jackson Street, Suite 2500 Tampa, Florida 33602
STATEMENT OF THE ISSUES
The issues in this case are whether Respondent violated section 458.331(1)(m), Florida Statutes, by failing to keep
legible medical records that justify the course of treatment of a patient, as set forth in the Second Amended Administrative Complaint, and, if so, what is the appropriate sanction.
PRELIMINARY STATEMENT
On August 30, 2015, the Department of Health (Petitioner or Department) referred an Amended Administrative Complaint against Cesar Augusto Velilla, M.D. (Respondent or Dr. Velilla), to the Division of Administrative Hearings. Respondent disputed allegations of fact in the complaint and requested a formal hearing. A Second Amended Administrative Complaint was filed on March 4, 2016, following an Order granting a motion to amend the complaint.
Prior to hearing, Petitioner withdrew the allegations in Count I of the Second Amended Administrative Complaint. The parties filed a Joint Pre-hearing Stipulation on March 21, 2016, including stipulations of fact, which are incorporated below.
The final hearing took place on March 30, 2016. Official recognition was given to three orders of the Board of Medicine. In support of the allegations in Count II, Petitioner offered the testimony of John J. Obi, M.D., and offered Exhibits P-1 through P-7, which were accepted into evidence. Exhibit P-2, a deposition of Patient C.A., was admitted with the caveat that it was hearsay and could not alone support a finding of fact, but could only be used to supplement or explain other evidence. The
parties substituted a redacted copy of Patient C.A.'s deposition as Exhibit P-2, deleting irrelevant material, which was submitted on April 11, 2016.
Respondent testified himself, and offered the testimony of Pedro Soler, M.D., accepted as an expert in plastic surgery, and that of Richard Sandler, M.D., accepted as an expert in internal medicine with a subspecialty in nephrology. Respondent also offered seven exhibits, R-1, R-3, R-4, R-6, R-8, R-13, and R-15, all of which were admitted.
The Transcript was filed on May 13, 2016. Both parties timely filed proposed recommended orders, which were considered in preparation of this Recommended Order.
Except as otherwise indicated, citations to the Florida Statutes or rules of the Florida Administrative Code refer to the versions in effect in February 2011, the time the violations were allegedly committed.
FINDINGS OF FACT
The Department is the state agency charged with regulating the practice of medicine pursuant to section 20.43, chapter 456, and chapter 458, Florida Statutes (2015). The Board of Medicine is charged with final agency action with respect to physicians licensed pursuant to chapter 458.
Dr. Velilla is a licensed physician in the state of Florida, having been issued license number ME 98818.
Dr. Velilla's address of record is 12709 Miramar Parkway Miramar, Florida 33027. Dr. Velilla has been a medical director at Evolution MD since the summer of 2010.
Dr. Velilla was licensed to practice medicine in the state of Florida during all times relevant to Petitioner's Second Amended Administrative Complaint.
Dr. Velilla is Board-certified in internal medicine by the American Board of Internal Medicine.
On or about December 29, 2010, Patient C.A. consulted with Dr. Velilla regarding possible abdominal liposuction and fat transfer to the gluteal area. These are cosmetic surgery procedures, undertaken with the object of enhancing the patient's appearance, and are purely elective.
On or about February 10, 2011, Dr. Velilla performed an evaluation of Patient C.A. and ordered routine pre-operative laboratory studies.
The laboratory report prepared by First Quality Laboratory indicated readings within normal limits for blood urea nitrogen (BUN) at 19.8 and creatinine serum at .7, but an abnormally high BUN/creatinine ratio reading of 30.43. It showed an abnormally high globulin reading at 3.40, an abnormally low INR reading of .79, an abnormally low MCH reading of 25.2, and an abnormally low MCHC reading of 30.7.
On or about February 15, 2011, Dr. Velilla reviewed Patient C.A.'s pre-operative laboratory report results. He placed a checkmark next to the high BUN/creatinine reading and the low INR reading. He wrote "Rev." with the date and signed his name on each page.
Dr. Velilla testified that he performed a glomerular filtration rate test, a calculation used to check on the functioning of the kidneys, and the result indicated normal renal function. He testified that a BUN/creatinine ratio outside of the normal range could be caused by several factors, and that after his assessment, the reading was not of concern to him in proceeding to surgery.
Dr. Velilla did not make any notation on Patient C.A.'s medical records to indicate how or why he concluded that the abnormal BUN/creatinine ratio reading was not of concern.
On February 24, 2011, Patient C.A. filled out a "General Consent" form. Patient C.A. agreed to disclose her medical history, authorized the release of medical records for certain purposes, agreed to use skin care products as directed, and acknowledged possible side effects from the use of skin care products. The form also stated, "I understand that Cesar Velilla,
M.D. P.A. services generally consist of a series of treatment [sic] to achieve maximum benefit, and this consent shall apply to
all services rendered to me by Cesar Velilla, M.D., P.A., including ongoing or intermittent treatments."
On February 24, 2011, Patient C.A. filled out a "Medical History" form. Patient C.A. indicated she was not under the care of a dermatologist, did not have a history of erythema ab igne, was not on any mood-altering or anti-depression medication, had never used Accutane, had never had laser hair removal, had no recent tanning or sun exposure, had no thick or raised scars from cuts or burns, and had never had local anesthesia with lidocaine. The form did not ask for information about any prior abdominal procedures, previous liposuction treatments, multiple pregnancies, or abdominal hernias.
On February 24, 2011, Patient C.A. signed a "Consent for Laser-Assisted Lipolysis Procedure SLIM LIPOSCULPT." The form did not include consent for fat transfer to the gluteal area or describe risks or possible complications of that procedure. Patient C.A. also signed a "Consent for Local Aneshesia [sic]" form.
As Dr. Obi testified, the risks from a fat transfer procedure are generally the same as those of the liposuction procedure; although with a fat transfer, you have additional potential for fat embolism.
On or about February 24, 2011, Dr. Velilla performed liposuction of the abdomen and thighs with fat transfer to the gluteal area on Patient C.A. at Evolution MD.
Patient C.A.'s liposuction was not the "Slim Liposculpt" laser-assisted procedure. The testimony was clear that the "Slim Liposculpt" procedure would use a laser to melt the fat before liposuction, which could not be done on Patient C.A. because the fat was to be transferred. There was testimony that a laser could be used to improve skin retraction, however.
As Dr. Velilla testified, Patient C.A. had requested the fat transfer in addition to the liposuction prior to the procedure. Dr. Velilla discussed the risks of both the liposuction and the fat transfer with Patient C.A., and she consented to have the procedure done. As Dr. Velilla testified, this consent was later documented on the operative report prepared sometime after the surgery and dated February 24, 2011, the date of the surgery.
Dr. Velilla's testimony was supplemented by the operative report, which stated in pertinent part:
The patient requested liposuction with fat transfer and understood and accepted risks including but not exclusive to bleeding, infection, anesthesia, scarring, pain, waves, bumps, ripples, contour deformities, numbness, skin staining, fluid collections, non- retraction of the skin, deep venous thrombosis, fat embolism, pulmonary embolism, death, necrotizing fasciitis, damage to
surrounding structures, need for revision surgery, poor aesthetic result and other unexpected occurrences. No guarantees were given or implied and the patient had no further questions prior to the procedure.
Other options including not having surgery were discussed and dismissed by the patient.
The operative report adequately documented Patient C.A.'s earlier oral informed consent for liposuction with fat transfer. Patient C.A. did not execute a written informed consent for the fat transfer prior to the procedure.
Dr. Velilla also noted in the operative report that the "patient physical examination and pre-operative blood work were within normal limits." Neither the operative report nor any other documentation indicated whether a complete physical examination or a focused physical examination was given, or what that examination consisted of.
Patient C.A. was scheduled for a second liposuction procedure on her arms on February 26, 2011. It was decided to defer the procedure on her arms to this later date in order to keep the amount of lidocaine at a safe level during the initial procedure.
On or about February 26, 2011, Patient C.A. presented to Evolution MD with complaints of nausea and mild pain. Dr. Velilla was not at the Evolution MD office.
Mild pain is to be expected on the second day after a fat transfer procedure, and nausea can be anticipated in some
patients who are taking opiods, as had been prescribed for Patient
C.A. There was insufficient competent evidence in the record to support a finding that Patient C.A.'s symptoms were unusual or that Dr. Velilla was ever informed of more serious symptoms in Patient C.A. that day.
Dr. Velilla spoke by telephone with an Evolution MD staff member about Patient C.A.'s symptoms and instructed the staff member to ask Patient C.A. to wait for his arrival at the office.
A "Progress Note" signed on February 26, 2011, by Ms. Amanda Santiago, of Dr. Velilla's office, indicated that
Patient C.A. said the pain and nausea were "due to the Vicodin." The note indicates that Dr. Velilla was called, that he stated he might stop the Vicodin and start Patient C.A. on Advil or Tylenol for pain, and that he asked that Patient C.A. be prepared for surgery. The note does not indicate that Dr. Velilla directed that Patient C.A.'s vital signs be taken, or that they were taken. The note states that Patient C.A. decided not to have the procedure on her arms done and that Dr. Velilla was again called. The note indicates that he asked the staff to take pictures of Patient C.A. and ask her to wait for him to arrive.
Dr. Velilla did not order Evolution MD staff to take Patient C.A.'s vital signs. Her vital signs were not recorded by Evolution MD staff on February 26, 2011.
Contrary to Dr. Velilla's request, Patient C.A. left Evolution MD on February 26, 2011, prior to Dr. Velilla's arrival at the office, and Evolution MD staff were unable to contact her.
On or about February 27, 2011, Patient C.A. presented to Coral Springs Medical Center where she was admitted with a diagnosis of severe dehydration, intravascular volume depletion, diarrhea, nausea, and vomiting. Subsequently, Patient C.A. was admitted to the intensive care unit.
Patient C.A. remained hospitalized until March 31, 2011.
Standards and Ultimate Facts
Dr. Obi is a surgeon specializing in plastic surgery.
He does not conduct laser-assisted liposuction, but performs what is known as "wet" or "super wet" liposuction, as was performed by Dr. Velilla in this case. He has been a Diplomate of the American Board of Plastic Surgery since 1982.
Dr. Obi reviewed Patient C.A.'s medical records from Evolution MD, other related records, and the Second Amended Administrative Complaint.
Taken as a whole, Dr. Obi's testimony with respect to the medical history documented for Patient C.A. was not clear and convincing. He testified that Patient C.A. was undergoing a significant operative procedure and that it involved multiple anatomic areas. He also noted that the history did not include information as to whether Patient C.A. had prior abdominal
surgical procedures, earlier liposuction, multiple pregnancies, or abdominal hernias. He testified that this information could indicate increased risks of injury and that this relevant history must be documented. Dr. Obi stated that in his opinion the patient history did not meet the minimum standards of the medical records rule.
On the other hand, Dr. Obi seemed to have only a partial understanding of what the medical records rule required, and he had no opinion on whether the patient history justified the course of treatment of Patient C.A.--the actual statutory standard that Dr. Velilla was charged with violating in the Second Amended Administrative Complaint:
Q. What does the rule say?
A: What does the rule say? The medical record rule I believe requires – I can't tell you verbatim what it says. It requires adequate documentation so that in the event that the care of a patient has to be transferred to another healthcare professional the documentation is adequate that the patient, that the professional could immediately step in and take over.
Q: Okay. You believe that's part of either the statute or the rule enacted by the Board of Medicine?
A: If the Board of Medicine is the group responsible for the medical record rule, then I would say yes.
Q: Okay. Have you reviewed what has been alleged in the amended administrative complaint, or second amended administrative
complaint, as to the statutory provision for medical record adequacy?
A: The statutory, I'm not sure that I have.
* * *
Q: And do you believe that the records fail to justify the course of treatment of the patient with those history findings?
A: That's not what I said. I didn't say it failed to justify. What I said is it wasn't complete.
Q: Okay, do you have an opinion as to whether the records fail to justify the course of treatment of the patient?
A: No.
Q: You don't have an opinion. Okay, thank you.
In contrast, Dr. Soler testified that in his opinion the patient history that was documented as part of Patient C.A.'s medical records did justify her course of treatment.
With respect to the physical examination, Dr. Obi noted that there was only a single line in the operative record stating that the physical examination was within normal limits. He noted that the documentation did not indicate what had been examined and did not record any specific findings or results of any examination that was conducted. However, he never offered an opinion that the record of the physical examination failed to justify the course of treatment of Patient C.A.
Dr. Soler testified that in his opinion, the record of the physical examination did justify the course of treatment of the patient.
Petitioner did not show by clear and convincing evidence that the documentation of Patient C.A.'s medical history and physical examination failed to justify her course of treatment.
Dr. Obi testified that the medical records should have contained more evaluation or explanation of the abnormal laboratory report results:
Q: And so was the check mark, when coupled with that note in the pre op, or in the operative report, sufficient documentation of Dr. Velilla's evaluation of the of the patient's pre-operative lab results?
A: In my opinion, no.
Q: And what do you base that on?
A: If you have an abnormal result, I think it is incumbent on you – it – depending on what the abnormality is, and depending on what your interpretation of that abnormality is, it's incumbent to explain it. Sometimes you need to repeat the tests. Sometimes it may be perfectly within normal limits, but on the laboratory sheet, if it says that it's high, or out of the range of normal, I think other than just check mark, I think you just acknowledge what your thoughts are.
Q: And do you remember if there was anything abnormal in Patient C.A.'s pre-operative laboratory results?
A: There was one area that I commented on. That was the BUN-creatinine ratio.
Q: And what is the BUN-creatinine ratio?
A: It's just a ratio of some parameters dealing with kidney function.
Q: Okay, and what does that lab result tell you about a patient, if anything?
A: Well, you know, it can call your attention to the area, I mean, it can tell you, you know, that the patient has some renal issues. It can tell you that the patient is, you know, potentially dehydrated, it can tell you that the patient, you know, is within normal. But if the values are – if one value is high and the other one is low, it may give you a, a high reading. And that's understandable, but all you need to do is document that.
It was Dr. Obi's opinion that the medical records failed to contain a sufficient evaluation or explanation of the abnormal BUN/creatinine ratio laboratory result. He acknowledged that the abnormal result was not necessarily indicative of a renal problem.
However, Dr. Obi also testified:
Q: Okay. Do you have an opinion as to whether those records are adequate to justify the course of treatment of the patient?
A: The failure to document the thought process on this ratio would, in and of itself, not prevent or preclude the operative procedure from being done, if that's your question.
At best, Dr. Obi's testimony was thus ambiguous as to whether or not failure to include an explanation of the abnormal laboratory result failed to justify the course of treatment of Patient C.A.
Dr. Soler testified that no other documentation or chart entry was required to address the lab report value in order to justify proceeding with the surgery. Dr. Sandler testified that the BUN/creatinine ratio was a renal-related test, but does not itself indicate kidney malfunction. Dr. Sandler also testified that in his opinion, no other documentation was needed prior to proceeding with the surgical procedure.
The Department did not clearly and convincingly show that the documentation in the medical records relating to abnormal laboratory results failed to justify the course of treatment of Patient C.A.
Dr. Obi testified that Dr. Velilla had a duty to order the taking of Patient C.A.'s vital signs since he was not yet in the office when she returned on February 26, 2011, the date the second liposuction had been scheduled. He testified that if the medical records rule "requires doing what's appropriate at each visit," then Patient C.A.'s records did not meet the requirements of that rule. He testified that if Patient C.A. was an "outlier" in that her symptoms were uncommon, the standard of care required that Patient C.A.'s vital signs be taken. Dr. Obi admitted that there was no documentation in the medical records to suggest that Dr. Velilla had ordered the staff at Evolution MD to take Patient C.A.'s vital signs, but he testified that the order should have been given and that it should have been documented.
Dr. Obi testified that there was no written documentation of an informed consent for the fat transfer and that the consent for the "Slim Liposculpt" procedure was consent for a procedure that was not done. Again, Dr. Obi seemed unfamiliar with the specific requirements of the medical records rule:
Q: And is, is the –is a written documentation of the fat transfer required by the medical record rule in this case?
A: In terms of the actual requirement, it would be my opinion that it should be required. Now, I can't say if it says that for every procedure, every surgical procedure, every invasive procedure, that a written consent must be documented; because obviously, you now, the patient consented. It's implied that the patient consented because she showed up for the procedure.
Dr. Obi testified that he was aware that the operative report contained statements that Patient C.A. had been informed of the risks of the fat transfer procedure and that she had specifically consented. He admitted he was unsure as to "which board, or organization, or outfit" requires a written informed consent.
Aggravating and Mitigating Factors
No evidence was introduced to show that Dr. Velilla has had any prior discipline imposed.
There was no evidence that Dr. Velilla was under any legal restraints in February 2011.
It was not shown that Dr. Velilla received any special pecuniary benefit or self-gain from his actions in February 2011.
It was not shown that the actions of Dr. Velilla in this case involved any trade or sale of controlled substances.
On May 17, 2014, Dr. Velilla received a certificate showing completion of an FMA educational activity conducted in Jacksonville, Florida, entitled "Quality Medical Record Keeping for Health Care Professionals."
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction pursuant to sections 120.569 and 120.57(1), Florida Statutes (2015).
A proceeding 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). Petitioner must prove the charges against Respondent by clear and convincing evidence. Fox v. Dep't of Health, 994 So. 2d
416, 418 (Fla. 1st DCA 2008)(citing Dep't of Banking & Fin. v.
Osborne Stern & Co., 670 So. 2d 932 (Fla. 1996)).
The clear and convincing standard of proof has been described by the Florida Supreme Court:
Clear 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 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 a firm belief or conviction, without hesitancy,
as to the truth of the allegations sought to be established.
In re Davey, 645 So. 2d 398, 404 (Fla. 1994)(quoting Slomowitz v.
Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983)). Although the clear and convincing standard of proof may be met where 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).
Disciplinary statutes and rules "must always be construed strictly in favor of the one against whom the penalty would be imposed and are never to be extended by construction." Griffis v. Fish & Wildlife Conserv. Comm'n, 57 So. 3d 929, 931
(Fla. 1st DCA 2011); Munch v. Dep't of Prof'l Reg., Div. of Real
Estate, 592 So. 2d 1136 (Fla. 1st DCA 1992).
Petitioner did not charge Respondent with violation of any Board of Medicine rule. Respondent was charged with violation of section 458.331(1), which provided, in relevant part:
The following acts constitute grounds for
. . . disciplinary action . . . .
* * *
(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of
treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
Petitioner charged in Count II that Respondent failed to keep legible medical records justifying the course of treatment of Patient C.A. Petitioner first alleges that Respondent failed to document a detailed and complete medical history and physical examination for Patient C.A. prior to her surgical procedure.
It was clearly shown that Patient C.A.'s medical records did not include any history of prior abdominal surgical procedures, earlier liposuction, multiple pregnancies, or abdominal hernias. All of this was important and relevant information. It was similarly shown that the only medical record of a physical examination was a single sentence contained in the operative report that the examination was within normal limits. However, there was no testimony that the records failed to justify the course of treatment of Patient C.A. Dr. Obi offered no such opinion, and Respondent's expert witnesses testified to the contrary.
Petitioner did not show by clear and convincing evidence that the minimal documentation of Patient C.A.'s history and the records of her physical examination failed to justify her course of treatment.
The complaint next alleges that Respondent failed to document his evaluation of the abnormal laboratory findings from February 10, 2011.
Respondent's notation in the operative report that Patient C.A.'s pre-operative blood work was "within normal limits" is strikingly brief. It was in fact undisputed that a few of those laboratory results were not within normal limits.1/ Respondent placed a checkmark next to the abnormally high BUN/creatinine ratio, indicating that he was aware of that abnormal result. Respondent testified that he conducted further calculations to determine that the abnormal reading did not indicate a renal condition. He admitted that he did not make any note of this or otherwise document why or how he had concluded that the abnormal reading did not preclude the procedure.
Dr. Obi testified that Respondent should have annotated the medical records with his thoughts about the BUN/creatinine ratio, or ensured that they reflected his evaluation or explanation of that result, rather than simply checking the high reading. He went on to testify, however, that in his opinion, Respondent's failure to document the thought process as to the lab result would not prevent or preclude the course of treatment.
Petitioner did not show by clear and convincing evidence that Respondent's medical records of laboratory tests failed to justify Patient C.A.'s course of treatment.
The complaint next alleges that Respondent failed to document ordering Evolution MD staff to take Patient C.A.'s vital signs on February 26, 2011.
As found above, Respondent did not order that Patient C.A.'s vital signs be taken on February 26, 2011, when she returned to Evolution MD. Dr. Obi testified that "good quality medical care" dictated that Respondent take her vital signs, or, since Respondent was not present, order an Evolution MD employee to do so. He testified that this was required because her symptoms were unusual, but there was no competent evidence of that in the record. While he noted it also would be necessary to take vital signs before the follow-up surgery, Patient C.A. decided not to have the surgery. Almost all of Dr. Obi's testimony was directed to this point: that in failing to direct that Patient C.A.'s vital signs be taken, Respondent violated a standard of care.
In Breesmen v. Department of Professional Regulation, Board of Medicine, 567 So. 2d 469, 471 (Fla. 1st DCA 1990), the
court held that without evidence that Dr. Breesmen had failed to properly record the medical treatment that had actually been administered, or that entries made were false or inaccurate, a charge of failure to keep sufficient medical records that concerned other treatment that had never been prescribed could not be supported. The court stated that, while the evidence may have
shown that Dr. Breesmen's actions were not those of a reasonably prudent physician, "section 458.331(1)(m) does not purport to encompass such standards." The circumstances here are similar. While it is not clear that the taking of vital signs itself necessarily constitutes a course of treatment,2/ charging a violation of record-keeping requirements as an indirect method of addressing a possible underlying standard of care violation is convoluted and inappropriate.
It was not proven by clear and convincing evidence that Respondent failed to keep legible medical records justifying the course of treatment of Patient C.A. by failing to document an order that had never been given to Evolution MD staff to take Patient C.A.'s vital signs.
Finally, the complaint charged that Respondent failed to document Patient C.A.'s consent for a fat transfer to the gluteal area.
As noted above, Respondent testified that Patient C.A. requested the fat transfer procedure in addition to the liposuction, that he discussed the risks of both the liposuction procedure and the fat transfer procedure with Patient C.A., and that she consented to have these procedures done. This consent was documented as a part of the operative report, dated
February 24, 2011, the date of the surgery.
While the written informed consent signed by Patient
C.A. prior to surgery was for a laser-assisted lipolysis procedure termed "Slim Liposculpt," and not the "wet" procedure with fat transfer that was actually conducted, this fact alone does not necessarily show a failure to document informed consent.
Section 766.103(4)(a), Florida Statutes, does indicate that a written informed consent raises a rebuttable presumption of valid consent, but in doing so, the statute necessarily also allows for oral informed consent. Respondent's testimony at hearing, bolstered and documented by the operative report, was that Patient C.A. was advised of the risks of the fat transfer and that she consented before the surgery. That evidence was not controverted by competent evidence in the record. While it is clear that informed consent must be given prior to surgery, it was not established that section 458.331(1)(m) precludes documentation of consent after the procedure, though of course this is almost never done as a practical matter.3/
Petitioner did not prove by clear and convincing evidence that Respondent failed to document Patient C.A.'s consent for the fat transfer procedure.4/
Petitioner did not show by clear and convincing evidence that Respondent failed to keep legible medical records that justified the course of treatment of Patient C.A., in violation of
section 458.331(1)(m), as charged in Count II of the Second Amended Administrative Complaint.
Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health, Board of Medicine, enter a final order dismissing the Second Amended Administrative Complaint against the professional license of Dr. Cesar Augusto Velilla.
DONE AND ENTERED this 8th day of June, 2016, in Tallahassee, Leon County, Florida.
S
F. SCOTT BOYD Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 8th day of June, 2016.
ENDNOTES
1/ If the statement that the blood work was "within normal limits" is interpreted to apply to each and every test result on the report, it was clearly incorrect. However, there was testimony that the statement could reasonably be taken to apply to the laboratory results as a whole, given the minor nature of the abnormalities. In any event, Petitioner did not charge or argue that the statement in the operative report was inaccurate.
2/ Florida Administrative Code Rule 64B8-9.003 was amended after Breesmen to require a licensed physician to maintain medical records with sufficient detail to clearly demonstrate why "an apparently indicated course of treatment" was not undertaken.
However, this language was subsequently removed on September 11, 2006, apparently in reaction to the case of Colbert v. Department of Health, 890 So. 2d 1165, 1166 n.2 (Fla. 1st DCA 2004).
Colbert had indicated the inapplicability of that rule language to the facts and noted that the rule language should be strictly construed.
3/ Testimony that a written informed consent is customary is not alone sufficient to establish the applicable standard. See Doctors Mem'l Hosp., Inc. v. Evans, 543 So. 2d 809, 812 (Fla. 1st DCA 1989).
4/ Even had Petitioner proven that consent was not documented, it is not clear that this type of record-keeping failure would necessarily fall within the statutory criteria. The Board of Medicine has held that, "logic dictates that while a physician's failure to explain the procedure to be performed or to obtain the patient's informed consent might warrant discipline, such a default would not prevent him from keeping impeccable medical records that justify the course of the patient's treatment in compliance with section 458.331(1)(m)." Dep't of Health, Bd. of Med. v. Scheinberg, Case No. 10-10047 (Fla. DOAH June 20, 2011; DOH Aug. 29, 2011).
COPIES FURNISHED:
Bruce Douglas Lamb, Esquire Gunster, Yoakley and Stewart, P.A.
401 East Jackson Street, Suite 2500 Tampa, Florida 33602
(eServed)
Zachary Bell, Esquire Yolonda Y. Green, Esquire Department of Health Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 (eServed)
Nichole C. Geary, General Counsel Department of Health
4052 Bald Cypress Way, Bin A-02 Tallahassee, Florida 32399-1701 (eServed)
Claudia Kemp, J.D., Executive Director Board of Medicine
Department of Health
4052 Bald Cypress Way, Bin C-03 Tallahassee, Florida 32399-3253 (eServed)
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Aug. 16, 2016 | Agency Final Order | |
| Jun. 08, 2016 | Recommended Order | Petitioner failed to show by clear and convincing evidence that Respondent failed to keep legible medical records that justified the course of treatment of the patient. |
