The Issue The issue is whether Respondent is guilty of performing wrong-site surgery or performing a procedure without the patient's consent and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a physician in the state of Florida. His license number is ME 85786. Respondent is Board-certified in anesthesiology and pain management by the American Board of Anesthesiology. Respondent has not previously been disciplined by the Board of Medicine. Patient K. D. suffered a back injury in November 1998. Following a laminectomy, Patient K. D. continued to suffer from chronic low-back pain. She visited Respondent's pain management clinic for pain relief and has been quite satisfied with the treatment that she has received from Respondent. On February 14, 2003, one of Respondent's partners performed a right-side lumbar rhizotomy by pulsed radiofrequency. The purpose of this procedure is to relieve or eliminate pain in the lower back. When performed by pulsed radiofrequency, the rhizotomy would probably not have been successful if the patient still experiences pain two weeks after the procedure. Two weeks later, on February 28, Patient K. D. presented for a left-side lumbar rhizotomy, which Respondent was to perform. Immediately prior to the surgery on February 28, while Patient K. D. was in pre-op, Respondent performed a physical examination and observed that Patient K. D. indicated pain on the right side. In response to questioning, Patient K. D. confirmed that her right side was more painful than her left side. Respondent said that he would therefore perform a right-side lumbar rhizotomy. Patient K. D. did not disagree or object, but consented to the procedure--in the presence of two nurses, as well as Respondent. Immediately after their pre-op discussion, Patient K. D. was administered Versed, which produces an effect of amnesia. To some extent, this drug may cause some retrograde amnesia, so that Patient K. D. might not recall events immediately preceding the administration of the drug, such as her physical examination and conversation with Respondent in pre-op. Respondent performed a right-side lumbar rhizotomy without incident. However, immediately after the procedure, Patient K. D. said that she also suffered left-side pain and questioned why Respondent had performed the procedure on her right side. When Patient K. D. complained that transportation problems would make it hard for her to re-schedule a left-side procedure, Respondent performed a left-side procedure, on the same day, and he completed this procedure also without incident. Prior to the February 14 and 28 procedures, Patient K. D. signed consent forms. The consent form for the February 14 procedure identifies a right-side procedure, and the consent form (actually, there are two identical forms) for the February 28 procedure identifies a left-side procedure. The forms state: It has been explained to me that during the course of an operation, unforeseen conditions may be revealed that necessitate an extensive exchange or change of the original procedure or different procedures, and I therefore authorize and require my physician or surgeon . . . to perform such surgical procedures as are necessary and desirable in the exercise of his and/or their professional judgement. . . . Petitioner's expert witness opined that a change in location, even under the above-described circumstances, "should" have been documented on a consent form, but later conceded that this is not strictly necessary. On cross-examination, Petitioner's expert witness admitted that a patient may give informed consent verbally or by conduct. Petitioner's expert witness properly discredited Respondent's theory that he had some form of ongoing consent because the forms bore no expiration date. However, to the limited extent that Petitioner's expert witness implied a requirement for written informed consent, his opinion is unsupported by Florida law, as set forth below. In contrast to Petitioner's expert witness, Respondent's expert witness did not equivocate on the issue of the required form of informed consent. Relying largely on the testimony of Patient K. D., Respondent's expert witness testified that Respondent had obtained the informed consent of Patient K. D. to perform a second right-side procedure. Aside from the obvious advantages of a written informed consent, Respondent's expert witness convincingly testified that informed consent is a state of mind, not a signature on a piece of paper, and, by this standard, which is consistent with Florida law, as set forth below, Respondent had Patient K. D.'s informed consent to perform a second right-side procedure on February 28 and thus had been duly authorized to do so.
Recommendation It is RECOMMENDED that Petitioner dismiss the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 21st day of November, 2005, in Tallahassee, Leon County, Florida. S _ ROBERT E. MEALE 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 21st day of November, 2005. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Irving Levine Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Dennis A. Vandenberg Peterson Bernard 1550 Southern Boulevard West Palm Beach, Florida 33406
Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
The Issue The issue to be determined is whether Respondent violated sections 458.331(1)(m) and 458.331(1)(bb), Florida Statutes (2008),1/ as alleged in the Administrative Complaint and if so, what penalty should be imposed?
Findings Of Fact Petitioner is the state agency charged with the licensing and regulation of medical doctors pursuant to section 20.42 and chapters 456 and 458, Florida Statutes. At all times material to the allegations in the Administrative Complaint, Respondent was a medical doctor licensed in the State of Florida, having been issued license number ME 98868. At the time of alleged incident, Respondent was board certified in anesthesiology. He is now also board certified in pain management. On February 10, 2009, Respondent was working at the Tallahassee Outpatient Surgical Center (TOSC). His duties included performing interventional pain management procedures. Patient C.C. was, at the time of the incident, a 50- year-old male. On February 10, 2009, he was admitted to TOSC for a dorsal medial nerve branch block at the right cervical levels 5/6/7. Respondent was scheduled to perform the procedure. Linda Dix was a nurse at TOSC who was present during C.C.'s procedure. She described the process for admission and preparation for surgery at TOSC, which included each patient receiving a plan, an order for surgery, and an informed consent form. C.C.'s plan, which Respondent signed, indicated that he was to receive a right-side medial nerve branch block at cervical levels 5/6/7. A medial nerve branch block may also be called a dorsal medial branch block. The procedure is a diagnostic block to rule out the level and type of pain the patient is experiencing. In this case, C.C.'s medical records indicate that C.C. had a left- side medial nerve branch block performed one month prior to this scheduled procedure, and had received relief from pain. When a medial nerve branch block is performed, the patient is placed in the prone position on the procedure table, and prepped with a cleaning solution such as Betadine or chorhexidene. There is more than one way to perform the procedure itself. However, a c-arm fluoroscope is used to identify the cervical levels. Sometimes, the physician will numb the skin in a subcutaneous needle pathway before inserting the needle that is going to be advanced to the medial branch nerve. The decision to do so, for Respondent, includes consideration of the size of the patient, and how far the final needle will need to be advanced. While the needle for numbing the skin and the needle for the procedure itself are the same size, they may be different lengths depending on how much tissue will be penetrated. The medial branch nerve lies against the lateral, or side, of the vertebral body, and the fluoroscope guides the needle to the vertebral body. Once the needle makes contact with bone, the physician will aspirate to ensure it is not in a blood vessel. In this case, Respondent was aware of the patient plan and the patient was already draped when he entered the procedure room. C.C. had been prepped and the c-arm fluoroscope was positioned consistent with the method used by another surgeon who had worked at TOSC. Respondent requested that the technician position the fluoroscope in a true lateral position rather than a posterior oblique position. A pause procedure was performed, in which Respondent participated and acknowledged agreement. He used a needle as a marker to show where to inject the numbing medication. However, Respondent placed the needle on the left as opposed to the right side. Respondent began injecting Lidocaine into C.C.'s left side. Before he could finish the injection, Ms. Dix asked him to explain how the medication was going to reach the right-side nerve branches from the location of the injection. Respondent realized at that point that he had injected the Lidocaine into the wrong site for a right-side medial nerve branch block. Respondent immediately stopped injecting the Lidocaine. At that point, .25 ml of Lidocaine had been injected. Lidocaine is a numbing agent. Respondent explained the error to the patient, and then completed the procedure on the correct side. There is no dispute that the correct procedure, and the only procedure intended to be performed, was to be performed on the right side. There is also no dispute that a small amount of Lidocaine was injected into the left side. In the nurse's notes contained in C.C.'s medical records for TOSC, under Intraoperative medication, it is noted that .25 ml of Lidocaine was injected on the left side, and 3 ml of Lidocaine was injected on the right. Also noted are other medications used during the procedure. On the page of the medical records containing the surgical plan (Petitioner's Exhibit 2, page 32) dated February 10, 2009, a list of medications used during the procedure includes .25cc of Lidocaine on the left, and 3cc of Lidocaine on the right, with the notation "local." Respondent signed this page of C.C.'s medical records. In addition, an incident report separate from the medical records was generated. Respondent's procedure notes, which were dictated on February 16, 2009, make no mention of the injection of Lidocaine on the left side. He testified that he did not view the numbing of the left side as part of the procedure itself, but rather part of the preparation of the patient. Specifically, he testified: Q. And where in here did you document the injection of the lidocaine into the left side? A. It was not documented in the procedure note. That only reflects the procedure that was performed on the correct side. Q. And why didn't you document that you injected lidocaine into the incorrect side in this procedure note that you're required to prepare? A. I have no particular reason for not doing it. We were doing 20-plus procedures a day, and I was just dictating and keeping up with the procedure notes, and I only dictated what was performed on the correct site. The chart had documented the error, and we had done the appropriate procedures for reporting the medical error, and so I relied on the rest of the chart to the complete the record as a whole.
Recommendation Upon consideration of the facts found and conclusions of law reached, it is RECOMMENDED: That the Board of Medicine enter a final order finding that Respondent violated section 456.072(1)(bb), as alleged in Count I of the Administrative Complaint; that it find Respondent did not violate section 458.331(1)(m), as alleged in Count II; and that as a penalty for Count I Respondent receive a letter of concern, pay a $2,500 fine, attend five hours of risk management continuing medical education, present a one-hour lecture on wrong-site surgery, and perform 50 hours of community service. DONE AND ENTERED this 29th day of December, 2010, in Tallahassee, Leon County, Florida. S LISA SHEARER NELSON 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 29th day of December, 2010.
