P2-24-C] Jeb Bush John O. Agwunobi, M.D., M.B.A. Governor Secretary February 3, 2004 Ann Luchini Clerk's Office A Division of Administrative Hearings CY The De Soto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 RE: DOH v. Charles Lankau, M.D. ESE- Chips, DOAH Case Number 01-3028 PL. . : DOH Case Number 1997-15338 Dear Ms. Luchini: Enclosed please find a copy of the final order and the opinion from the Third District Court of Appeal of Florida concerning the above referenced case. I realize that the Division of Administrative Hearings has closed its case. However, based on the review of the docket on your website, your office did not receive the final order or the decision of the District Court of Appeal. A review of your website does not indicate receipt of either of these documents or the correct status of this case. Therefore, I am enclosing these documents so that you have a complete record. Thank you for your time and attention to this matter. Asgistant General Counsel JET/tgc Enclosures 4052 Bald Cypress Way Bin C-65 e Tallahassee, FL 32399-3265 Final Order No. DOH-02-0334- FOF-MOA FILED DATE -. o2 Department of Healt! STATE OF FLORIDA By: Vick 2 venon BOARD OF MEDICINE Deputy Agency Clerk DEPARTMENT OF HEALTH 2 + _ con ee nn Petitioner, DOAH Case No. 01:3028PL? a Case No. 97-15338. © 5 @ vs. 2 . YY w CHARLES A. LANKAU, MD, a a wh a Respondent. FINAL ORDER ; THIS MATTER came before the Board of Medicine (hereinafter “the Board”) for final action pursuant to Section 120.57(1)(I), Florida Statutes, at a duly-noticed public meeting held on February 1, 2002, in Jacksonville, Florida, for the purpose of considering the Recommended Order issued by the Administrative Law Judge in the above-styled case. The Petitioner was represented by John Terrel, Senior Attorney, Agency for Health Care Administration. The Respondent was present at the Board meeting, and represented by W. Sam Holland, Esquire | . After a review of the complete record in this matter, including consideration of the Administrative Law Judge’s Recommended Order, a copy of which is attached hereto as Exhibit A, the exceptions filed by Petitioner, and the arguments of each party, the Board makes the following findings and conclusions: EXCEPTIONS TO FINDINGS OF FACT 1. Petitioner filed an exception to 47 of the Recommended Order (hereinafter “RO”) wherein the Administrative Law Judge (hereinafter “ALJ”} found 1 that “The title [of attending physician] in this context serves as a record-keeping function.” The Board granted the exception to strike this language on the grounds that the record contains no competent substantial evidence that “attending physician” when referring to the admitting physician is a “record-keeping function.” See, Exhibit 4, pp. 7-8; Gosalbez deposition, p. 96-97. In addition, in supervising residents, the attending physician has both the ethical and a legal responsibility for the overall care of the individual patient and for the supervision of the resident involved in the care of that patient. 2. Petitioner filed an exception to 416 of the RO wherein the ALJ found that “E.R.’s surgery was, assigned to Dr. Leopoldo Malvezzi (Malvezzi), a second year surgical fellow working under Lankau’s supervision.” The Board granted the exception to strike this paragraph as not supported by competent substantial evidence. The unrebutted evidence shows that Dr. Malvezzi did not have operating room privileges at the hospital, and if he wanted to operas, it was under the privileges of the attending physician (Tr. 202-203, 222, 292). Furthermore, this finding contradicts the finding in 423 of the RO that acknowledges that fellows at Miami do not have operating room privileges. Accordingly, thera is no evidentiary basis to conclude that E.R.’s surgery was assigned to the second-year fellow. The surgery was assigned to the Respondent. 3. Petitioner filed an exception to ¥ 23 of the RO wherein the ALJ found that “Paradoxically, fellows at Miami Childrén’s do not technically hold operating room privileges. . .” to strike the word “technically.” The Board granted the exception to strike the. word “technically” on the grounds that there is no evidence in the record that the lack of operating room privileges is a technicality. 4. Petitioner filed an exception to (27 of the RO wherein the ALJ found that “Although Lankau was listed as the ‘surgeon of record’ for E.R. on hospital documents, this too was largely a convention of hospital record keeping rather than a mandate that only Lankau would perform procedures on the patient.” The Board granted the exception on the grounds that the record contains no competent substantial evidence to support this finding. All the experts in the case, including . _the Respondent's own experts, and all written post-operative reports acknowledge that the Respondent was both the attending physician and the surgeon of record. Further, the correct consent forms identify Respondent as the person who would be responsible for the surgery and cystoscopy. To relegate this role to a mere “convention of hospital record keeping” ignores all of the testimony taken in this case from the experts. The surgeon of record is the person who has ethical, legal, and medical responsibility for overall care of the individual patient in the ‘operating room, whether performing surgery or supervising the surgery of others.’ 5. Petitioner filed an exception to 28 of the RO whéréin’ the ALJ found that “Lankau was however, in the surgical suite, physically removed from the sterile field.” Petitioner’s exception is denied, on the grounds that whether Respondent was or was not in the sterile field is not relevant to the determination of whether Respondent departed from the standard of care. However, the Board determined that the finding that Respondent was not required to be present in the operating room is a conclusion af law stated as a finding of fact. The conclusion of law is incorrect, and the language “nor even to be present” is stricken from 428. 6. Petitioner filed an exception to 430 of the RO wherein the ALJ found that “To Lankau, Malvezzi, and to all of the experts in the case, this result reasonably caused them to suspect that they had confirmed the location of an obstruction in the ureter.” The exception is granted in part and denied in part. The Board granted the request to strike the word “reasonably” from this finding as unnecessary. However, the experts did express that opinion and the request to strike the language “an to all of the experts in the case” is denied. 7. Petitioner filed an exception to (31 of the RO, which exception was withdrawn. 8. Petitioner filed an exception to 433 of the RO, wherein the ALJ found that “For reasons which the record does not reveal, E. R. was prepped and draped and served up to Malvezzi with her left flank exposed. It. was thus inevitable, at that point, that Malvezzi concluded that the initial incision should be made on the teft side.” With regard to the terminology “served up to,” the exception is granted; the appropriate terminology is “presented to.” In addition, tHe conclusion that the patient was presented “to Malvezzi” is not supported by competent substantial evidence. The ALJ failed to understand the role of the surgeon or record or attending surgeon. The finding will read “presented to Malvezzi and Respondent.” 9. With regard to the exception to 33 wherein the ALJ found that it was inevitable that the incision would be made on the correct side is granted. As a standard of medical practice, it is not inevitable that a surgeon operate on the wrong side if the patient is presented that way. Instead, it is a failure of the surgeon to know the patient. 10. Petitioner filed an exception to {34 of the RO wherein the ALJ found: “... Petitioner did not present any competent evidence which would permit the trier of fact to move beyond speculation in developing a theory as to how the wrong site surgery came to pass, and there is no evidence which links Lankau to any violation of the standard of care with respect to E.R.” The exception is granted, and following language is stricken: “and there is not evidence which links Lankau to any violation of the standard of care with respect to E.R.” The evidence is overwhelming, far exceeding the standard of “clear and convincing,” that this Respondent was present at and directed the actions of the second year fellow for the left flank surgical exploration (Tr. 160, 216; Pet. Ex. 1, 9; Erhard Depo p. 58; Gosalbez Depo, p. 110; Tr. 322-323; Tr. 346-347) Respondent was the attending physician and the surgeon of record for Patient E.R., and owed the child a duty of care to know the patient, and ensure-that. the surgery took place at the correct site. It was an act of omission for Respondent to stand by a and do nothing when the fellow began exploring the wrong side of this patient. 11. Petitioner filed an exception to 735 of the RO wherein the ALJ found” “More specifically, the record is devoid of any evidence that Lankau committed any errors or omissions which resulted in the wrong site surgery.” The exception is granted and 435 is stricken. Respondent was present and directed the fellow to perform the cystoscopy. Respondent was present, prepped and ready to participate, when the fellow started the left flank exploration. There were both acts of commission and omission by Respondent in how he rendered care and treatment to this patient. He can not absolve himself of this responsibility simply because blame can also be shared with the fellow, the nurse, etc. According to the testimony of Mr. Vives, the scrub technician, Respondent was present as soon as the patient was prepared for surgery. Mr. Vives testified that Respondent was scrubbed and present when the initial incision was made. Respondent did nothing even though he had reviewed all relevant X-rays of the patient prior to surgery (paragraph 29 of the Recommended Order). ° 12. Petitioner filed an exception to 442 of the RO wherein the ALJ found: “Almost immediately after the incision was made, it became obvious that the child did not have a left kidney . . .” to which Respondent did not object at consideration of this case. Therefore, the exception is granted, and 442 of the RO will be revised to read: “After the incision was made and during the exploration, it became obvious that the child did not have a left kidney...” It was obvious BEFORE the incision was made that the child did not have a left kidney. The X-ray.that Respondent reviewed, as well as the medical records, confirmed that the child did not have a left kidney. Moreover, the evidence is unrebutted that Lankau was present before the incision was made. Respondent indicates in his own medical record, that he dictated, that: the left flank was approached through a oblique incision in the anterior left flank. The retroperitoneal dissection revealed kidney present and a review of x-rays at that point showed that we were on the wrong side.” Respondent later testified that he had meant to say that no kidney was found. It was obvious that the error was not found until the exploration was well under way and Respondent was present during the exploration. 13. Petitioner filed an exception to (43 of the RO wherein the ALJ found: Yet, at the moment the error became known to them, the surgeons set emotion aside and did what. was needed to be done to correct the error and properly treat the child. The exception is granted and 443 stricken. This paragraph is mere commentary by. the ALJ and contains no specific finding of fact. As stated by Respondent’s | counsel, the paragraph is superfluous because it doesn’t matter one way or the other what happened afterwards. 14. Petitioner filed an exception to 445 of the RO wherein the ALJ found: The evidence establishes a breakdown of the record-keeping and surgical site verification protocols which led to the wrong site surgery performed on E.R. There is no evidence that Lankau was directly responsible for even one element of the breakdown. The exception to 445 is granted and the paragraph is stricken. The’ paragraph is totally unnecessary because 934 addresses the breakdown of the record keeping and all of the problems. In addition, the evidence overwhelmingly establishes that the cause of the wrong site surgery on this 10-year-old patient was Respondent’s failure to prevent an exploration of the wrong side along with Respondent’s directive to the fellow to perform the cystoscopy with pyelogram on the wrong side. Respondent participated in the breakdown by also failing to note in his handwritten operative report.that the consent for the exploration of the left side was incomplete and therefore inadequate. The consent form failed to identify the surgeon of record and was inadequate. Rather than address this error, Respondent merely proceeded with the surgery and did nothing while standing at the fellow’s side while the error was made. 15. Petitioner filed an exception to 46 of the RO wherein the ALJ found: To the contrary, with respect to Lankau’s role in the care and treatment E. R. received at Miami Children’s, the evidence establishes that his involvement with the patient was entirely appropriate to her symptoms and her medical history. , : The exception to 446 is granted and the sentence is stricken. This finding is devoid of any evidentiary support. The patient’s medical records show that she had no left kidney, and that her symptoms were to the right kidney. The patient’s attending physician and surgeon of record owed her a duty to read the medical records and review the medical history before directing the cystoscopy and standing by doing nothing while an exploration was performed on the wrong side by his fellow. Lankau’s involvement was not appropriate because he failed to do the most basic of requirements. ¢ 16, Petitioner filed an exception to two 4€48 of the RO. In the first paragraph numbered 48, the ALJ found: The standard of care appropriate to the facts and circumstances of this case is that Lankau was required to be available to address any complications that may arise from the surgical procedures which he permitted Malvezzi to perform. Lankau fulfilled this requirement at all times with respect to E.R. The exception to the first paragraph numbered 48 is denied. 17. Petitioner filed an exception to the second 448 of the RO wherein the ALJ found that in the context of a surgical fellowship, it would be entirely inappropriate for the head of the program to hold the hand, either literally or figuratively, of the surgical fellow. Respondent did not object to striking the language, as it is irrelevant to the issue of Respondent's duties as the surgeon of record and the attending surgeon. The exception to this language is granted and the sentence will be stricken. 18. Petitioner filed an exception to 149 of the RO wherein the ALJ found that it was Respondent’s obligation to be available to take over in the event of unforeseen complications. The exception to § 49 is denied. 19. Petitioner filed an exception to 450 of the RO wherein the ALJ found: The unnecessary insult to E. R.’s body, inexcusable as it was, was not caused by any direct error or omission on Lankau’s * part for which discipline against his license will lie. The exception to 450 is granted and is hereby stricken. This is a coneluéion of law masked as a finding of fact. This Board is charged with reviewing the entiré record © in this case and determining whether discipline will lie againgt the Respondent's license. This paragraph also ignores the clear and convincing testimony from Respondent, the medical records and the testimony of the scrub tech, all of which show that the Respondent directed the cystoscopy on the wrong side and stood by doing nothing while the exploration took place on the wrong side.. Respondent failed to meet the applicable standard of care. FINDINGS OF FACT 1. The Administrative Law Judge’s findings of fact are hereby approved, adopted, and incorporated herein as amended by the exceptions granted. 2. There is competent, substantial evidence to support the Administrative Law Judge’s findings of fact as amended and adopted by the Board. EXCEPTIONS TO CONCLUSIONS OF LAW 1. Petitioner filed an exception to 453 of the RO wherein the ALJ concluded that Petitioner did not satisfy its burden of proof. The exception to 453 is granted., The record overwhelmingly supports by clear and convincing evidence that ‘ Respondent breached the standard of care. Respondent was responsible for the care and treatment of this patient. Respondent's responsibility to his patient as attending physician and surgeon of record required him to review the patient's records so that this error would not occur under his supervision. 2. Petitioner filed an exception to 455 of the RO wherein the ALJ concluded that the record failed to establish that Respondent breached any applicable standard of care, and that there was no evidence that Lankau committed any errors-or omissions which were connected in any way to the wrong site surgery. The exception to 455 is granted as not being supported by competent substantial evidence. Paragraph 55 is stricken, and is replaced with the following conclusion of law: The record in this case establishes that Lankau breached the standard of care. 10 3. Respondent filed an exception to {55 of the RO and requested that the findings in {55 be considered a finding of fact rather than conclusion of law. The exception is denied. CONCLUSIONS OF LAW 1. The Board has jurisdiction over this matter pursuant to the provisions of Sections 120.569 and 120.57(1) and Chapter 480, Florida Statutes. 2. The Administrative Law Judge’s conclusions of law in ¢€ 51, 52 and 54 are hereby approved, adopted and incorporated herein. 3. The Administrative Law Judge's conclusions of law in (54 are approved . as amended. 4. The Administrative Law Judge’s conclusion of law in 755 is rejected. 5. The record in this case establishes that Respondent breached the standard of care, in violation of Section 458.331(1)(t), Florida Statutes. 6. There is competent substantial evidence to support the Board’s findings and conclusions. PENALTY IT IS THEREFORE ORDERED AND ADJUDGED: © 4 ae 1. Respondent shall pay a fine in the amount of $5,000 to the Board within one year from the date this Final Order is filed. 2. Respondent shall pay the costs associated with this case in the amount of $10,112.56.within one year from the date this Final Order is filed. 11 3. Within one year from the date this.Final Order is filed, Respondent shall present a one hour lecture to fellow attending physicians at the hospital at which he maintains staff privileges. The lecture shall address the subject of wrong site surgery. Documentation from hospital administrator and chief-of-staff of completion of said lecture shall be provided to the Board’s Probationer’s Committee. 4. In mitigation, the Board finds that Respondent immediately recognized what the problem was and was forthcoming regarding the error, and Respondent serves in an academic practice. This Final Order shall become effective upon filing with the clerk of the Department of Health. ° DONE AND ORDERED this@@o day of TEEMUGNY , 2002. BOARD OF MEDICINE Larry cPherson, Board Director for Zachariah P. Zachariah, MD, Chair NOTICE OF RIGHT TO JUDICIAL REVIEW UNLESS WAIVED Pursuant to Section 120.569, Florida Statutes, any substantially affected person is hereby notified that they may appeal this Final Order by filing one copy of a Notice of Appeal with the clerk of the Department of Health and by filing the filing fee and one copy of the Notice of Appeal with the District Court of Appeal within 30 days of the date this Final Order is filed. 12 CERTIFICATE OF SERVICE | HEREBY CERTIFY that a true and correct copy of the foregoing has been furnished by U.S. Mail to CHARLES A. LANKAU, MD, c/o W. Sam Holland, Esquire, 200 S. Biscayne Bivd., Suite 800, Miami FL 33131, and Florence Synder Rivas, Division of Administrative Hearings, 1230 Apalachee Parkway, Tallahassee FL 32399-1550 and and by inter-office mail to Nancy Snurkowski, Chief-Practitioner Regulation, Agency for Health Care Administration, 2727 Mahan Drive, Tallahassee FL 32308-5403 and Lisa Pease, Senior Attorney-Appeals, Agency for Health Care Administration, 2727 Mahan Drive, Ft. Knox #3, Tallahassee FL 32308, this tiff, day of _(\41- A__) 2002. F:\USERS\ADMIN\LEE\MEDICINE\ORDERS\LANKAU2.02.wpd 13

Docket for Case No: 01-003028PL

Orders for Case No: 01-003028PL