STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, Petitioner, V. CASE NO. 2009-20248 STEVEN DAVID GELBARD, M.D., Respondent. ADMINISTRATIVE COMPLAINT COMES NOW Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Steven David Gelbard, 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 and Chapters 456 and Chapter 458, Florida Statutes. 2. At all times material to this Complaint, Respondent was a licensed physician within the State of Florida, having been issued license number ME 59560. DOH v. Steven David Gelbard, M.D., Case Number 2010-20248 i Filed December 9, 2011 3:25 PM Division of Administrative Hearings 3. | Respondent’s address of record is 150 South Andrews Avenue, Suite #350, Pompano Beach, Florida 33069. 4. Respondent specializes in the area of Neurosurgery but is not board certified in this area by the American Board of Neurosurgeons or any other board recognized by the Florida Board of Medicine. 5. On or about July 9, 2009, Patient N.R., a then fifty-six year old female, had anterior cervical discectomies and fusion with instrumentation at C3-4, C4-5, C5-6, and C6-7, performed by Respondent at Jackson North Medical Center (JNMC), 6. Following this procedure, Patient N.R. suffered a spinal cord injury that resulted in quadriparesis (a paralysis caused by illness or injury to a human that results in the partial or total loss of use of all of their limbs and torso); during post-operative recovery, Patient N.R. was found to have a screw that pulled out and hardware displacement. 7. On or about July 24, 2009, Respondent performed a circumferential, anterior and posterior, surgery that included a corpectomy (a surgical procedure that involves removing part of the vertebral body) at C7, installation of new hardware, and posterior to C3 to Ti replacement of DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 2 instrumentation and fusion on Patient N.R. Patient N.R. underwent three (3) separate spinal surgeries with Respondent. 8. Following surgery, Patient N.R. was transferred to an inpatient rehabilitation center. In or around this time, Patient N.R. developed a posterior cervical wound dehiscence, drainage, and a staph epi infection. 9. Onor about August 23, 2009, Respondent performed a wound debridement and packed Patient N.R.'s wound with a Sani-cloth Plus (Sani- cloth) wipes. Sani-Cloth, which contains antibacterial and germicidal properties, is a material that is typically used for disinfecting hard surfaces, and is not approved as a packing material for any wound nor is it intended to be introduced into the human body. It clearly states on the packaging not for use on human skin. 7 10. There is no indication in the medical record that Respondent discussed and/or obtained fully informed written consent from Patient N.R. to use Sani-cloth as a packing material for her wound. 11. Respondent ordered that Patient N.R. receive additional antibiotics and surgically closed, leaving the Sani-cloth material in Patient N.R. In or between August 23, 2009 and September 4, 2010, Respondent packed Patient N.R.’s wound with Sani-cloths around 4-5 times. DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 3 12. Nurse P.J., was told to take pictures of Patient N.R.'s wound. It was at this time that she saw that the wound was packed with around one or two complete Sani-cloths. Patient N.R. pointed directly at the container of Sani-cloths when asked what Respondent had packed the wound with. 13. On or about September 4, 2009, Patient N.R.'s care was taken over by Dr. L and Dr. R., after Respondent was asked to step aside. Patient N.R. continued to suffer from pain and required continued wound care. 14. On or about September 9, 2009, Dr. L. and Dr. R., went into the OR to perform another wound debridement and wound vac. At this time, a foreign object, the Sani-cloth was discovered, packed within Patient N.R.'s wound. A pathology report conducted described the materials as two irregular pieces of paper-like material with straight borders measuring 5x4x0.1 c.m. 15. On or about October 1, 2009, Dr. L. and Dr. R., proceeded with wound debridement, muscle flap coverage, and primary wound closure. Patient N.R.'s wound did eventually heal. 16. Respondent allegedly packed Patient N.R. with the Sani-cloth materials when no one else was present in the room stating to nurses and DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 4 staff he could do the procedure alone; Respondent allegedly stated when questioned about his use of the materials, that Sani-cloths clean everything, and appeared to see no problem with using the material. 17. Respondent asserted that he used the Sani-cloth materials because the hospital was out of the iodaform material that he initially requested; the representative for JNMC states that the hospital has never been out of iodaform and/or appropriate packing materials. 18. On or about September 2, 2009, Respondent was issued a precautionary suspension of his staff privileges at JNMC; Respondent permanently relinquished his clinical privileges and medical staff membership at JNMC on or about March 8, 2010. 19. Section 456.042, Florida Statutes (2009), provides ‘that a practitioner must submit updates of required information to his practitioner profile, within 15 days after the final activity that renders such information a fact. The Department of Health shall update each practitioner's practitioner profile periodically. An updated profile is subject to the same requirements as an original profile. DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 5 20. As of May 24, 2011, Respondent has not updated his practitioner profile to reflect the relinquishment of his clinical privileges and medical staff membership at JNMC. COUNT ONE 21. Petitioner realleges and fully incorporates paragraphs one (1) through twenty (20) as if fully stated herein. 22. Section 458.331(1)(t), Florida Statutes (2009), subjects a doctor to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2009). Section 456.50, Florida Statutes (2009), defines medical malpractice as the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure. 23. Level of care, skill, and treatment recognized in general law related to health care licensure means the standard of care specified in Section 766.102, Florida Statutes (2009). Section 766.102(1), Florida Statutes (2009), defines the standard of care to mean“. . . The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 6 circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. .. .” 24. Respondent failed to meet the prevailing standard of care in regard to Patient N.R. in one or more of the following ways: a) b) c) d) e) 25. by failing to provide proper post-operative treatment and care to Patient N.R.; by using Sani-cloths as a packing material when packing Patient N.R.'s wound instead of an appropriate packing material; by inserting a material within Patient N.R. that is not fit for human use and/or the insertion into the human body on Patient N.R.; by failing to develop and/or implement an appropriate treatment plan for Patient N.R.; by knowingly placing and leaving, repeatedly a foreign body that is not commonly used in surgery within Patient N.R. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2009), by committing medical malpractice. DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 7 COUNT TWO 26. Petitioner realleges and fully incorporates paragraphs one (1) through twenty (20) as if fully stated herein. 27. Section 456.072(1)(cc), Florida Statutes (2009), provides that leaving a foreign body in a patient, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia commonly used in surgical, examination, or other diagnostic procedures, is grounds for disciplinary action by the Board and/or Department. For the purposes of this paragraph, it shall be legally presumed that retention of a foreign body is not in the best interest of the patient and is not within the standard of care of the profession, regardless of the intent of the professional. 28. Respondent knowingly and intentionally left Sani-cloths, a foreign body which he used as packing material, within Patient N.R. 29. Based on the foregoing, Respondent has violated Section 456.072(1)(cc), Florida Statutes (2009), by leaving a foreign body within Patient N.R. COUNT THREE 30. Petitioner realleges and fully incorporates paragraphs one (1) through twenty (20) as if fully stated herein. DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 8 31. Section 458.331(1)(u), Florida Statutes (2009), provides that performing any procedure or prescribing any therapy which, by the prevailing standards of medical practice in the community, would constitute experimentation on a human subject, without first obtaining full, informed, and written consent is grounds for disciplinary action by the board and/or Department. 32. Respondent performed the procedure of packing Patient N.R.'s wound with a material, Sani-cloth, that is not intended to be used on or within the human body, without obtaining full, informed, written consent from Patient N.R.; this action within the prevailing standards of medical practice in the community constitutes experimentation on a human subject. 33. Based on the foregoing Respondent has violated Section 458.331(1)(u), Florida Statutes (2009). COUNT FOUR 34. Petitioner realleges and fully incorporates paragraphs one (1) through twenty (20) as if fully stated herein. 35. Section 456.072(1)(w), Florida Statutes (2009), provides that failing to comply with the requirements for profiling and credentialing, including, but not limited to, failing to provide initial information, failing to DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 9 timely provide updated information, or making misleading, untrue, deceptive, or fraudulent representations on a profile, credentialing, or initial or renewal licensure application, is grounds for disciplinary action by the board and/or Department. 36. Respondent relinquished his staff membership and clinical privileges from JNMC on or about March 8, 2010. As of May 24, 2011, Respondent has not updated his practitioner profile with this information, which is well outside of the allotted 15 days provided to update this information. 37. Based on the foregoing, Respondent has violated Section 456.072(1)(w), Florida Statutes (2009), by failing to update his practitioner profile with required information in a timely manner. WHEREFORE, Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: 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. DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 10 Ns ant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 ED oT OF HEALTH DEPART TY CLERK Florida Bar # 032569 x Ganlro FO (850) 245-4640 CER JON 28 20" (850) 245-4681 FAX PCP Date: June 24, 2011 PCP Members: — El-Bahri, Espinola & Mullins DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 DOH v. Steven David Gelbard, M.D. Case No.: 2009-20248 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. DOH v. Steven David Gelbard, M.D., Case Number 2010-15320 12

Docket for Case No: 11-006249PL