Aug 4 2006 11:45 fug 4 2006 11:44 P.O5 STATE OF FLORIDA = DEPARTMENT OF HEALTH 2 ons ao ho DEPARTMENT OF HEALTH, = PETITIONER, v. CASE NO. 2005-63004 LUCIEN ARMAND, M.D., | RESPONDENT. DMINI TIV [NT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files ‘ris Administrative Complaint before the Board of Medicine against Resyondens Lucien Armand, M.D., and in support thereof alleges: 1. Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed medical doctor within the state of Florida, having been issued license number ME 33997, Aug 4 2006 11:45 fug 4 2006 11:44 P. O06 3. Respondent’s address of record is 4100 South Hospital Drive, Suite 108, Plantation, Florida 33317. 4. Respondent is certified in general surgery by the American Board of Surgery. 5. At all times material hereto, Respondent practiced at 4100 South Hospital Drive, Suite 108, Plantation, Florida 33317, and he was registered to perform office surgeries at that location until June 2004. 6. Section 458,.309(3), Florida Statutes (2003), requires that “[A]ll physicians who perform level 2 procedures lasting more than 5 minutes and all level 3 surgical procedures in an office setting must register the office with the department unless that office is licensed as a facility pursuant to chapter 395. The department shall inspect the physician's office annually unless the office is accredited by a nationally recognized accrediting agency or an accrediting organization subsequently approved by the Board of Medicine.” 7. In order to carry out the requirements of Section 458.309(3), Florida Statutes (2003), the Board of Medicine enacted Rules 64B8-9.009, 64B8-9.0091, and 6488-9.0092, Florida Administrative Code (FAC), related to office surgery and office surgery facilities. Among other things, these rules require that the surgeon maintain complete records of each surgical JAPSU\Medical\DIANE\ACs-General\Armand 2005-63004\Armand 2005-63004 AC 2-17-06.dac 2 Aug 4 2006 11:45 dug 4 2006 11:44 P.O? procedure, including anesthesia records, written informed consent that includes risks, consent, type of anesthesia and anesthesia provider; a surgical log of all Level II and Level III surgical procedures performed, | - including type of procedure, type of anesthesia, duration of the procedure, type of post-operative care, and any adverse incidents; required equipment to provide for patient’s oxygenation, ventilation, circulation. and temperature to be continually monitored; a policy and procedure manual containing the duties and responsibilities of all personnel, quality _ assessment and improvement systems, cleaning, sterilization, and infection control, and emergency procedures; a risk management program, adverse incident reports; appropriate required signage; resuscitative equipment and supplies that shall include a full and current crash cart, including an extensive list of resuscitative medications; personnel information on the surgeon and all staff, including BLS and ACLS certifications; emergency procedures; and facilities and equipment for monitored post-anesthesia recovery in the office. 8. On or about November 16, 2004, Respondent submitted an application for Office Surgery Registration to the Department. When the Department began review of that application, it found that Respondent's Florida Academy of Cosmetic Surgeons (FLACS) accreditation had expired JAPSU\Medical\DIANE\ACs-General\ Armand 2005-63004\Annand 2005-63004 AC 2-17-06.doe 3 Aug 4 2006 11:47 fug 4 2006 11:44 P. 08 in June 2004. Respondent’s office surgery facility has not been reaccredited after the FLACS accreditation expired. 9. As provided in Rule 64B8-9.0091(1), Florida Administrative Code, a physician who performs Level II or Level lil office surgery is responsible for ensuring that every office in which the physician practices that surgery is registered and is in compliance with the requirements of Rule 64B8-9.009, Florida Administrative Code. 10. On or about April 4, 2005, the Department conducted an Office Surgery Inspection in response to Respondent's November 16, 2004, application for accreditation. That inspection revealed numerous. major deficiencies, which included the following: a. Non-compliance with pre-operative evaluations; b. Non-compliance with —patient/procedure —_—srecords requirements; c. Non-compliance with informed consent requirements; d. —_ Lack of surgical logs; @. Lack of records of post-operative (pre-op) care; f. Lack of a policy and procedure manual; g. Lack of a risk management program; h. Lack of adverse incident reporting; JAPSU\Medical\DLANE\ACs-General\ Armand 2003-63004\Armand 2005-63004 AC 2-17-06.dac 4 processes, 11, was expired. Aug 4 2006 11:47 dug 4 2006 11:46 P.09 Lack of required signage; Lack of basic life support (BLS) certification; Lack of advanced cardiac life support (ACLS) certification; Lack of required equipment and supplies; Lack of crash cart resuscitative medications; Lack of recovery monitoring; Lack of emergency procedures; Expiration of all drugs in the office; Lack of calibration of gases since February 2002; Lack of functioning defiorilator; Lack of the previous FLACS inspection for review; Lack of an infection control policy; Lack of sterilization policies; and Lack of evidence of any drills or quality assurance As stated above, every medication found in the operating room Inspectors found the following medication and their expiration dates in the operating room: Lidocaine 2% exp 11/01 Benadryl x 5 exp 24 3 Dopamine exp 12/01 Robinul x 2 exp 12/04 Aminophylline x 2 exp 9/02 TAPS U\Medical\DIANE\ACs-General\Anmand 2005-63004\Armand 2005-63004 AC 2-17-06.doc 3 Aug 4 2006 11:47 fug 4 2006 11:46 P.10 Epi 1:10,000 exp 7/02 Perot m4 5b 20/0 aicium i Tubocaine Chioride exp 10/02 x 23 Procanamide exp urosemide exp 5/02 Nitroquick exp 2/02 Solumedrol exp 2/04 Verapamil exp 11/02 Mag Sulfate exp 10/02 Dilantin exp 4202 Narcan exp 2/04 Heparin exp 4/03 Inderal exp 6/02 ep Loc exp bie? Atropine x 3 exp 6/00 Breviblock exp 4/99 Phenergan exp 3/01 Phenergan exp 2/01 Droperidol x 5 exp bgt Ephedrine x 4 exp 6/02 Ephedrine x 2 exp 3/02 Neostigmine ~ exp 28 Neostigmine exp 1 494 imbcx exp 7/01 Trandate exp 1/02 Robinul a exp. 8/03. _ Romazicon exp 10/02 Verapamil exp $f 1 Ventilin Inhaler exp 10/99 12. The inspectors found a narcotics log which showed Respondent performed an abdominoplasty on D.V. on May 28, 2004, under general anesthesia administered by P. Jacobson, M.D., an anesthesiologist. There was no surgical log in the facility, 13. Inspectors subsequently determined from a medical chart review that Patient D.V. received pre-operative medications from Respondent on May 27, 2004. Respondent then performed an abdominoplasty on May 28, 2004, with Philip Jacobson, M.D., performing anesthesia, which included intubation, The chart contained a general JAPSU\MedicalD1ANE\ACs-General\ Armand 2005-63004\Armand 2005-63004 AC 2-17-06.doc 6 Aug 4 2006 11:47 fug 4 2006 11:46 P.11 consent, but this consent did not include risks or possible complications. The verbiage required by Rule 64B8-9.009(2)(a), Florida Administrative Code (FAC), was not included. 14. Patient D.V’s chart contained an immediate pre-op form, but it was only partially completed by someone other than Respondent. Respondent did not sign the immediate pre-op form. The chart contained no recovery notes, no discharge order by Respondent, no post-op vital signs and no operative report. A specimen was sent to pathology at Broward General Medical Center, but the chart contained no pathology report. nee ee ante Ct see ce smn _ bse 15. Respondent’s application for accreditation listed the other medical staff involved in the office surgery or anesthesia as Philip Jacobson, M.D., License No. ME 70215, and Barry Miller, ARNP, a certified registered nurse anesthetist (CRNA) holding License No. RN 1471922. Even though Rule 64B8-9,009, FAC, requires that a personnel file on all staff be in the facility and that the file contain a current BLS/ACLS license, there was no file for Dr. Jacobson, no BLS or ACLS license for Dr. Jacobson, and expired BLS and ACLS licenses for CRNA Miller. 16. Respondent was not present for the inspection, but the inspectors contacted him by telephone. He verbally stated that he did not JAPSU\Medical\ DIANE\ACs-Cieneral\Armand 2005-63004\Armand 2005-63004 AC 2-17-06.doe q Aug 4 2006 11:48 fug 4 2006 11:46 P.12 want the facility inspected, that he wanted to withdraw the accreditation application, and that he had not performed Level II or II procedures since 2002. When confronted with the May 28, 2004, case, he denied having performed it; however when told about the anesthesia record, which indicated that Patient D.V. had been intubated and monitored (making it Level II or Level III surgery), Respondent ended the conversation. 17. At the time of the inspection, the operating room in Respondent's office was fully equipped with an anesthesia machine, operating room table, monitors and a defibrillator (albeit non-functioning). COUNT ONE 18. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein, 19. Section 458.331(1)(nn), Florida Statutes (2004), provides that violating any provision of Chapter 458 or Chapter 456, or any rules adopted pursuant thereto, constitutes grounds for disciplinary action by the Board- of Medicine. 20. The aforesaid inspection revealed deficiencies which included, but were not limited to, lack of compliance with numerous requirements of Rules 64B8-9.009, 64B8-9.0091, and 64B8-9.0092, Florida JAPSU\Medical\DLANE\ACs-General\Armand 2005-63004\ Armand 2005-63004 AC 2-17-06.doc 8 Aug 4 2006 11:48 fug 4 2006 11:46 P.13 Administrative Code, which specifically address the standards regarding requirements for office surgery facilities. Those major deficiencies are detailed above. 21. The aforementioned deficiencies create an immediate danger to the safety of patients. Respondent has not submitted any corrective action plan. 22. Rule 64B8-9.0091(1)(f), FAC, provides that disciplinary action may be taken when the deficiencies are so great as to constitute an immediate and imminent danger to the public. 23... Based on. the. foregoing, Respondent. has violated . Section 458.331(1)(nn), Florida Statutes (2004), by violating Rules 64B8-9.009, 64B8-9.0091, and 64B8-9.0092, FAC, as detailed above. COUNT TWO 24. Petitioner realleges and incorporates paragraphs one (1) through seven (7), ten (10), and twelve (12) through sixteen (16) as if fully set forth in this count. 25. Section 458.331(1)(m), Florida Statutes (2003), provides that 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 J:APSU\Mcdical\DIANE\ACs-General\ Armand 2005-63004\Armand 2005-63004 AC 2-17-06.doe 9 Aug 4 2006 11:48 fug 4 2006 11:46 P14 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, constitutes grounds for disciplinary action. 26. Respondent failed to document one or more of the following in the medical chart of patient D.V.: a. A consent that includes the risks or possible complications; b. The verbiage required by Rule 64B8-9.009(2)(a), Florida Administrative Code (FAC): ~ c. An immediate pre-op form that was completed by Respondent; An immediate pre-op form that was signed by Respondent; @. Recovery notes; f. Discharge order; g. — Post-op vital signs; h. Operative report; and i, A pathology report. 27, Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2003), by 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 JAPSU\Medical\DIANE\ACS-GeneraltArmand 2005-63004\Annand 2005-63004 AC 2-17-06.doc 10 Aug 4 2006 11:48 Aug 4 2006 11:46 PL15 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 | WHEREFORE, the Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the | Board deems appropriate. | SIGNED this Zz ay of "77 ten eA , 2006. M. Rony Francois, M.D., M.S.P.H., Ph.D. Secretary, Department of Health FILED Oi AN QEPARTMENT OF HEALTH Diane K. Kiesling gq LY DEPUTY CLERK - Assistant General Colingel_ . CLERK CJhearac. Wilco DOH Prosecution Services Unit DATE, ane ee eSclle, 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Florida Bar # 00233285 (850) 245-4640 Ext.8127 (850) 245-4680 FAX IAPSU\Medical\DLANE\ACs-General\ Armand 2005-63004\Armand 2003-63004 AC 2-17-06,doe I} Aug 4 2006 11:49 fug 4 2006 11:46 P.16 DKK PCP: March 24, 2006 PCP Members: El-Bahri, & Tucker NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested, NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related. to the investigation and. prosecution: of this matter. — Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. JAPSU\Medical\DIANE\ACs-General\Annand 2005-63004\Armand 2005-63004 AC 2-17-06.doc 12

Docket for Case No: 06-002823PL