Florida Board of Medicine: Update and Overview

1. Florida Board of Medicine: Update and Overview Jason J. Rosenberg, M.D., FACS DATE

2. Overview • Who is the Board of Medicine • Licensure Statistics • Accessing Information • Committees, Councils & Meetings • Licensure Renewal • Practitioner Profiles • Expert Witnesses • Disciplinary Process & Implications • Board’s Activities • Pain-management Registration and Inspection Program • Office Surgery Registration and Inspection Program • Maintenance of Licensure • Wrong site surgery/person/procedure • Re-entry into practice

3. Who is the Board of Medicine? • Mission: To promote, protect and improve the health of all people in Florida. • Judge • Enforce legislation • Define quality • License • Communicate

4. Medical Board Structure The Medical Board is a group of volunteers who are charged with upholding the Medical Practice Act for the State of Florida. • Twelve physician members • Three consumer members All Members of the Board are appointed by the Governor.

5. Leadership

6. Licensure Statistics Profession # of licensees Medical Physicians 67,455 Anesthesiologist Assistants 60 Physician Assistants 5,108 Statistics taken from the MQA Annual Report July 1, 2010 – June 30, 2011

7. Accessing Information • Board of Medicine web page • http://www.doh.state.fl.us/mqa/medical/ • Board of Medicine Interested Parties List (Mailman) • Go to website above to sign up • Address, telephone, fax and email • 4052 Bald Cypress Way, Bin C03, Tallahassee, FL 32399 • (850) 245-4131 • (850) 488-9325 • MQA_Medicine@doh.state.fl.us

8. Board Committees Major standing committees include: • Credentials Committee • Interviews license applicants whose prior history, including malpractice cases, raises questions of concern regarding the ability to practice with skill and safety, or questions about an applicant’s performance in medical school or prior practice in other jurisdictions • Rules/Legislative Committee • Develops recommendations for amendment of Board rules or creation of new rules, to clarify practice standards or to impose requirements to strengthen patient protection and quality of care. This committee also makes recommendations for Florida’s annual legislative session

9. Board Committees continued . . . • Probationers Committee • Monitors compliance of licensees who have been disciplined and placed under conditions or probation; reviews required reports of compliance and requires personal appearances from probationers as part of the ongoing monitoring, until such time as the conditions of probation are fulfilled • Surgical Care/Quality Assurance Committee • Determines necessary and appropriate revisions to the rule to strengthen patient safety and minimize the risk factors that contribute to adverse patient incidents; addresses issues related to quality of care and standards of practice; formulates policy recommendations for the full Board’s consideration, studies quality of care issues as they arise, and organizes and conducts symposia on special topics (e.g., treatment of obesity, disruptive physician).

10. Board Committees continued . . . • North and South Probable Cause Panels • Review investigations of complaints filed against licensees and determine whether the investigation materials reflect probable cause that the licensee violated regulatory requirements, including requirements relating to standards of care and misconduct. When probable cause is found, disciplinary action is initiated by the panels for final action by the full Board, after the licensee is afforded due process rights

11. Other Committees • Finance & Statistics Committee • Review the Board’s budgetary standing and to create/track statistics that assist the Board in making policy decisions • Expert Witness Committee • Approves expert witnesses to be used by investigators and probable cause panels in reviewing complaint investigations for a determination that standards of care were violated • Joint Anesthesiologist Assistant Committee (MD’s and DO’s share responsibilities) • Approve applicants for licensure as well as making recommendations for rule creation and/or changes relating to the regulation of this profession • .

12. Other Committees Continued • Communication, Education and Information Committee • This committee is tasked with developing proactive communication strategies in an effort to educate and inform applicants, licensees and the public about the roles and activities of the Board of Medicine and the laws and rules and ethics regulating the practice of medicine

13. Councils under the Board Purview • Council on Physician Assistants • Council’s duties: • Certification of applicants for licensure • Development of rules regulating physician assistants • Making recommendations to the Board regarding all matters relating to physician assistants • Board’s duties: • Approve and adopt identical rule language recommended by the Council, or return the recommendation to the Council • Disciplinary actions against licensees

14. Councils under the Board Purview continued . . . • Dietetic-Nutrition Council • Council’s duties: • Certification of applicants for licensure • Development of rules regulating the practice of dietetics and nutrition counseling • Making recommendations to the Board regarding all matters relating to the practice of dietetics and nutrition counseling • Board’s duties: • Approval and adoption of administrative rules • Disciplinary action against licensees

15. Councils under the Board Purview continued . . . • Electrolysis Council • Council’s duties: • Certification of applicants for licensure • Development of rules regulating the practice of electrolysis • Making recommendations to the Board regarding all matters relating to the practice of electrolysis • Board’s duties: • Approval and adoption of administrative rules • Disciplinary action against licensees

16. Meetings • The Board of Medicine meets 6 times per year to handle hearings and Board business (February, April, June, August, October, December) • All meetings are open to the public and physicians may receive CME credit for attending one of the Board Meetings.

17. Licensure Renewal • Florida physicians must renew their license every two years. • Renew ONLINE at www.doh.state.fl.us/mqaservices • To renew a Florida license physicians are required to obtain a minimum of 40 hours of continuing medical education. • 2 hours in prevention of medical errors • 38 hours of general CME • Every third renewal: 2 hours Domestic Violence, 2 hours prevention of medical errors and 36 hours of general CME • Physicians practicing in Pain-management Clinics that are not Board certified as outlined in Rule 64B8-9.0131, FAC are required to have 15 hours CME in pain-management per year. • Recent reduction of renewal fee to $391 (includes background check fee and unlicensed activity fee)

18. Licensure Renewal The Prevention of Medical Errors course has specific requirements including a study of root cause analysis, error reduction, prevention and patient safety, and the 5 most mis-diagnosed medical conditions in Florida during the previous biennium and those conditions are: • 1. Diagnosis of cancer • 2. Diagnosis of surgical complications • 3. Diagnosis of acute abdomen related conditions • 4. Diagnosis of pregnancy related conditions • 5. Diagnosis of neurological conditions This list is subject to change every two years. Be sure to read Rule 64B8-13.005, FAC for the most recent changes to the rule.

19. Renewal of Licensure continued . . . • Retired status – if you elect to place your license in a retired status, you are not permitted to practice medicine at all, including the writing of prescriptions

20. Practitioner Profiles • Must be updated within 15 days of any change [s. 456.042, F.S.] • Mandatory fields: • Primary practice address • Secondary practice address • Staff privileges • Other state licensure • Year began practicing • Education and training • Other health related degrees • Professional and postgraduate training • Academic appointments • Specialty certification • Financial responsibility • Criminal Offenses • Final disciplinary action (multiple categories) • Actions on staff privileges • Liability claims

21. Practitioner Profiles continued . . . • View the Practitioner’s Guide to Completing and Updating the Profile at www.doh.state.fl.us/MQA/profiling

22. Are you interested in serving as an Expert Witness? The Department of Health is looking for certified physicians, in a wide range of specialty areas to serve as experts in a volunteer or paid status. For more information, contact the Irene Lake at (850) 245-4444 extension 8212

23. Disciplinary Process • Grounds for disciplinary action • S. 458.331(1), Florida Statutes • S. 457.072(1), Florida Statutes • http://www.leg.state.fl.us/statutes/index.cfm • Disciplinary guidelines • Rule 64B8-8.001, Florida Administrative Code • https://www.flrules.org/Default.asp

24. DISCIPLINARY PROCESS Mediation Not Disputed Final Order = Confidential = Public Record Complaint 2d Citation Issued Agency ConsumerServices Unit Closure/Referral to Other Agencies as Non-Jurisdictional OR Closure as Legally Non-sufficient Investigation Probable Cause Panel Selected by the respective professional board from the Department of Health Prosecution Attorney Review Legal Services Section Citation Formal Hearing Before DOAH (Contests Charges) Agency Director, If No formal Probable Cause Panel Exists Informal Hearing Before Respective Board (No Dispute) Final Board Action and Disposition Findings: Case Disposition Final Order Imposing Discipline Filed with Department of Health Hearing Waived Before Respective Board (No Dispute) No Probable Cause Found Probable Cause Found Dismissal/ Closure Administrative Complaint Filed With Department of Health Election of Rights By Licensee Stipulation/Settlement by Licensee to Respective Board for Approval Appeal Procedures To District Court of Appeals

25. Disciplinary Statistics • 4,838 complaints filed • 1,631 found legally sufficient • 229 resolved through Final Orders • 200 resolved through citations (1st citation is not discipline) MQA Annual Report July 1, 2010 – June 30, 2011

26. Implications of Disciplinary Action • If you have licenses in multiple states and have had action on a license in one state, you should report that action to the other states. • Disciplinary action is reportable to the Healthcare Integrity Protection Databank, Federation of State Medical Boards, Drug Enforcement Agency and the American Medical Association. • Disciplinary action may have an effect on medical malpractice insurance, HMO coverage, staff privileges and other state licensure.

27. Tips to avoid discipline • Update profile [s. 456.072, F.S.] • Notify Board before you move or close your practice [s. 456.035, 458.319, 458.327, Rule 64B8-10.002] • Do not pre-sign prescriptions [s. 458.331(1)(aa] • Maintain medical records on friends, family and employees [s. 458.331(1)(r), 458.331(1)(m)] • Patient boundaries [s. 458.329, 458.331(1)(j)]

28. Tips to avoid discipline • Do not Internet prescribe [s. 458.331(1)(t), Rule 64B8-9.014] • Pre-approve any advertisement of your services – disclaimer required [s. 456.062, Rule 64B8-11] • Know the fees you can charge for copies of medical records [Rule 64B8-10.003] • Know the legible prescription laws [s. 456.43, s. 668 and Rule 64B8-3.005] • Know the controlled substance prescribing laws [s. 456.42, and Rule 64B8-9.013] • Notify patients of adverse incidents [s. 395.0197, 395.1051, 456.0575]

29. Help for impaired & rehabilitation for disable physicians • The Board has an excellent evaluation and rehabilitation program that is a phone call away: Professional Resource Network (800) 888-8776 • For most practitioners, this is and remains a confidential process that offers help • Program recently expanded to include medical students

30. What’s on the Board’s Radar? • Pain Management • Office Surgery Regulation • Maintenance of Licensure • Wrong site/person/procedures • Re-Entry into Practice • Communication, Education and Information

31. Pain Management • In 2007, 8,620 drug related deaths (approx 5% of all deaths in Florida) 2007 Medical Examiners Commission Drug Report • The Board continues to support the prescription drug monitoring program [eForcse]. • The Board has met several times with the Boards of Osteopathic Medicine, Pharmacy and Nursing along with other stakeholders to address issues involving patient deaths related to prescription medications • The Board, in conjunction with the Federation of State Medical Boards (FSMB), is attempting to obtain funding to send FSMB’s publication “Responsible Opioid Prescribing, A Physician’s Guide” to all physicians licensed in our state.

32. Office Surgery Registration Program • Every licensed physician who holds an active Florida license and performs Level II surgical procedures in Florida with a maximum planned duration of more than five (5) minutes or any Level III office surgery, as fully defined in Rule 64B8-9.009, F.A.C., shall register the office with the Department of Health.

33. Office Surgery Registration Program • Total number of facilities registered = 411 • Total number of physicians registered = 641 From Board of Medicine Annual Report for Fiscal Year 2010-2011

34. Wrong site surgery/procedure/person statistics The Board of Medicine recently held a Wrong site surgery/procedure/person (WSS) workshop. Results indicate that most of the cases result from a breakdown of the process of communication between doctor, patient and staff as related to the time out procedure and do not necessarily reflect any lack of skill or judgment on the part of the operating surgeon. We will continue to explore better ways to educate physicians and staff on more effective ways to perform the time out and pause prior to beginning the procedure in order to help eliminate this recurring but preventable problem. • During fiscal year 2010-2011, 4,838 complaints were filed. • Of those complaints, 1,631 complaints were found to be legally sufficient • Of those, the Board took 229 disciplinary actions against physicians. • Of the 229 disciplinary actions taken, 19 were based on wrong site/procedure/person violations • The Board is currently reviewing the Pause Rule [Rule 64B8-9.007, FAC] to continue addressing Wrong Site cases.

35. Some risk factors and/or causes • Breakdown in communication • Surgical site not marked or not marked properly • Patient records, X-rays or other diagnostic studies not available in OR for verification • Incomplete pre-op assessment • Staffing issues and/or other distractions • Emergency cases • Unusual time pressures • Multiple patient surgeries scheduled on same day with a cancellation • Multiple procedures on same patient • X-rays reversed • Pause is performed and surgeon subsequently leaves the room

36. Areas of improvement: • Pause Rule • 3 R’s Poster Campaign • Executive Director and Board Members presents information about preventing wrong site surgery at training programs, hospitals, universities, medical organization and other entities throughout Florida • Meeting with parties who have a goal to improve patient safety • Patient Safety Corporation • Florida Medical Association • Board of Nursing • Board of Osteopathic Medicine

37. 64B8-9.007Standards of Practice – The Pause Rule. • The Board of Medicine interprets the standard of care requirement of Section 458.331(1)(t), F.S., and the delegation of duties restrictions of Section 458.331(1)(w), F.S., with regard to surgery as follows: • (1) The ultimate responsibility for diagnosing and treating medical and surgical problems is that of the licensed doctor of medicine or osteopathy who is to perform the procedure. In addition, it is the responsibility of the treating physician or an equivalently trained doctor of medicine or osteopathy or a physician practicing within a Board approved postgraduate training program to explain the procedure to and obtain the informed consent of the patient. It is not necessary, however, that the treating physician obtain or witness the signature of the patient on the written form evidencing informed consent.

38. (2) This rule is intended to prevent wrong site, wrong side, wrong patient and wrong surgeries/procedures by requiring the team to pause prior to the initiation of the surgery/procedure to confirm the side, site, patient identity, and surgery/procedure. (a) Definition of Surgery/Procedure. As used herein, “surgery/procedure” means the incision or curettage of tissue or an organ, insertion of natural or artificial implants, electro-convulsive therapy, endoscopic procedure or other procedure requiring the administration of anesthesia or an anesthetic agent. Minor surgeries/procedures such as excision of skin lesions, moles, warts, cysts, lipomas and repair of lacerations or surgery limited to the skin and subcutaneous tissue performed under topical or local anesthesia not involving drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient are exempt from the following requirements.

39. (b) Except in life-threatening emergencies requiring immediate resuscitative measures, once the patient has been prepared for the elective surgery/procedure and the team has been gathered and immediately prior to the initiation of any procedure, the team will pause and the physician(s) performing the procedure will verbally confirm the patient’s identification, the intended procedure and the correct surgical/procedure site. The operating physician shall not make any incision or perform any surgery or procedure prior to performing this required confirmation. The medical record shall specifically reflect when this confirmation procedure was completed and which personnel on the team confirmed each item. This requirement for confirmation applies to physicians performing procedures either in office settings or facilities licensed pursuant to Chapter 395, F.S., and shall be in addition to any other requirements that may be required by the office or facility. (c) The provisions of paragraph (b) shall be applicable to anesthesia providers prior to administering anesthesia or anesthetic agents, or performing regional blocks at any time both within or outside a surgery setting.

40. (3) Management of postsurgical care is the responsibility of the operating surgeon. (4) The operating surgeon can delegate discretionary postoperative activities to equivalently trained licensed doctors of medicine or osteopathy or to physicians practicing within Board approved postgraduate training programs. Delegation to any health care practitioner is permitted only if the other practitioner is supervised by the operating surgeon or an equivalently trained licensed doctor of medicine or osteopathy or a physician practicing within a Board approved postgraduate training program. Specific Authority 458.309 FS. Law Implemented 458.331(1)(t), (v), (w) FS. History–New 11-28-91, Formerly 21M-20.015, 21M-27.007, 61F6-27.007, 59R-9.007, Amended 2-18-04, 9-18-05, 4-25-06, 5-6-08.

41. What can you do to avoid this?

42. JCAHO recommendations: • Visit patient in the pre-op area • Mark the surgical site with the patient • Verify the records (patient chart, X-rays, diagnostic studies, etc) and have these available in the OR • Obtain oral verification in the OR by reading the consent • Take a time-out to verify 3 R’s and document • Monitor compliance with these steps

43. Making the incision on correct site of correct patient The Board accepts no excuse for wrong site surgery If you make the mistake, document it or the Board will increase the penalty If you make the mistake, advise the patient and/or the patient’s representative or the Board will increase the penalty

44. Although wrong site/procedure/patient surgery incidents are a very, very small percentage of surgical encounters, most if not all wrong site surgery is preventable. The cause of a wrong site surgery is a breakdown of communication in the preparatory process prior to performing the procedure. Careful use of the “Pause or Time-Out” prior to each step in the preparatory process can and will prevent wrong site surgery.

45. Re-entry into practice The Board is concerned about the competency of physicians who do not practice for a period of time for one reason or another and then return to practice. For this reason, the Board will be conducting workshops regarding re-entry into practice requirements to ensure the safety of patients in our state. Stay tuned to our web page for additional information and dates for the workshops.

46. QUESTIONS?