Osteopathic Statutes Chapter 64B15-6 Physician Assistant ...

64B15 BOARD OF OSTEOPATHIC MEDICINE

CHAPTER 64B15-6 PHYSICIAN ASSISTANT

64B15-6.001 Definitions. 64B15-6.002 Application for Licensure. 64B15-6.003 Physician Assistant Licensure. 64B15-6.0031 Change in Employment Status. 64B15-6.0035 Physician Assistant Licensure Renewal and Reactivation. 64B15-6.0036 Termination of Supervision. (Repealed) 64B15-6.00365 Dispensing Drugs. 64B15-6.0037 Requirements and Limitations of Prescribing Privileges. 64B15-6.0038 Formulary. 64B15-6.004 Requirements for Approval of Training Programs. 64B15-6.005 Grounds for Discipline. (Repealed) 64B15-6.006 Advertising. 64B15-6.010 Physician Assistant Performance. 64B15-6.0105 Notice of Noncompliance. 64B15-6.01051 Citation Authority. 64B15-6.011 Disciplinary Guidelines. 64B15-6.0115 Time Limitation for Payment of Administrative Fine. (Repealed) 64B15-6.012 HIV/AIDS Education. (Repealed) 64B15-6.013 Physician Assistant Fees. 64B15-6.014 Mediation.

64B15-6.001 Definitions. (1) The term “Primary Supervising Physician” as herein used refers to a physician licensed pursuant to Chapters 458 and 459,

F.S., who assumes responsibility and legal liability for the services rendered by the physician assistant(s) at all times the physician assistant is not under the supervision and control of an alternate supervising physician.

(2) The term “Alternate Supervising Physician” as herein used refers to the physician licensed pursuant to Chapter 458 or 459, F.S., who assumes responsibility and legal liability for the services rendered by the physician assistant while the physician assistant is under his or her supervision and control.

(3) The term “responsible supervision” as used herein refers to the ability of the supervising physician to responsibly exercise control and provide direction over the services of the physician assistant. In providing supervision, the supervising physician shall periodically review the physician assistant’s performance. It requires the easy availability or physical presence of the supervising physician to the physician assistant. In determining whether supervision is adequate, the following factors should be considered:

(a) The complexity of the task; (b) The risk to the patient; (c) The background, training and skill of the physician assistant; (d) The adequacy of the direction in terms of its form; (e) The setting in which the tasks are performed; (f) The availability of the supervising physician; (g) The necessity for immediate attention; and (h) The number of other persons that the supervising physician must supervise. (4) The term “direct supervision” as used herein refers to the physical presence of the supervising physician on the premises so

that the supervising physician is immediately available to the physician assistant when needed. (5) The term “indirect supervision” as used herein refers to the easy availability of the supervising physician to the physician

assistant, which includes the ability to communicate by telecommunications. The supervising physician must be within reasonable physical proximity.

(6) The term “recent graduate” as used herein refers to a person who completed the approved program no more than two years (24 months) prior to the date the application for licensure as a physician assistant was received.

(7) The term “fully licensed physician assistant” as used herein refers to those physician assistants who have successfully passed the NCCPA examination or other examination approved by the Board and have been issued a license other than a temporary license authorized under Sections 459.022(7), 458.347(7)(b)2. and 458.347(7)(f), F.S.

Specific Authority 459.005 FS. Law Implemented 459.022 FS. History–New 10-18-77, Formerly 21R-6.01, Amended 10-28-87, 4-18-89, 9-26-90, 3-16-92, Formerly 21R-6.001, Amended 2-20-94, Formerly 61F9-6.001, 59W-6.001, Amended 6-7-98, 3-17-99, 7-13-03.

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64B15-6.002 Application for Licensure. (1) All persons applying for licensure as a physician assistant shall submit an application to the Department on forms approved

by the Council and the Board and provided by the Department. (2) The application may not be used for more than one year from the date of original submission of the application and fee. The

fee to be paid at the time of application for licensure shall be as set forth in Rule 64B15-6.013, F.A.C. After one year from the date that the original application and fee have been received in the Council office, a new application and fee shall be required from any applicant who desires licensure as a physician assistant.

(3) All application information must be submitted no later than 15 days prior to the Council meeting at which the applicant desires the application to be considered.

Specific Authority 459.005 FS. Law Implemented 459.022 FS. History–New 10-18-77, Formerly 21R-6.02, Amended 10-28-87, 4-21-88, 5-20-91, 3-16-92, Formerly 21R-6.002, 61F9-6.002, 59W-6.002, Amended 6-7-98, 3-10-02, 2-23-04.

64B15-6.003 Physician Assistant Licensure. (1) Requirements for Licensure. All applicants for licensure as physician assistants shall submit an application to the

Department on forms approved by the Council and Boards and provided by the Department. The applicant must meet all of the requirements of Section 458.347(7) or 459.022(7), F.S., and the applicant must submit two personalized and individualized letters of recommendation from physicians. Letters of recommendation must be composed and signed by the applicant’s supervising physician, or, for recent graduates, the preceptor physician, and give details of the applicant's clinical skills and ability. Each letter must be addressed to and directed to the Council on Physician Assistants and must have been written no more than six months prior to the filing of the application.

(2) Applicants for licensure who have not passed the NCCPA licensure examination within five (5) attempts shall be required to complete a minimum of three (3) months in a full-time review course at an accredited physician assistant program approved by the Chair of the Physician Assistant Committee, which completion shall be documented by a letter signed by the head of the program stating that the applicant has satisfactorily completed the course.

(3) Restrictions. For purposes of carrying out the provisions of Sections 458.347(7) and 459.022(7)(e), F.S., every physician assistant is prohibited from being supervised by any physician whose license to practice osteopathic medicine is on probation.

(4) The applicant must submit notarized statements containing the following information: (a) Completion of three hours of all Category I, American Osteopathic Association or American Medical Association

Continuing Medical Education which includes the topics of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome: the disease and its spectrum of clinical manifestations; epidemiology of the disease; related infections including TB; treatment, counseling, and prevention; transmission from healthcare worker to patient and patient to healthcare worker; universal precautions and isolation techniques; and legal issues related to the disease. If the applicant has not already completed the required continuing medical education, upon submission of an affidavit of good cause, the applicant will be allowed six months to complete this requirement.

(b) Completion of one hour of continuing medical education on domestic violence which includes information on the number of patients in that professional’s practice who are likely to be victims of domestic violence and the number who are likely to be perpetrators of domestic violence, screening procedures for determining whether a patient has any history of being either a victim or a perpetrator of domestic violence, and instruction on how to provide such patients with information on, or how to refer such patient to, resources in the local community, such as domestic violence centers and other advocacy groups, that provide legal aid, shelter, victim counseling, batterer counseling, or child protection services, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Osteopathic Association or American Medical Association Continuing Medical Education. Home study courses approved by the above agencies will be acceptable. If the applicant has not already completed the required continuing medical education, upon submission of an affidavit of good cause, the applicant will be allowed six months to complete this requirement.

(c) Completion of two hours of continuing medical education relating to prevention of medical errors which includes a study of root cause analysis, error reduction and prevention, and patient safety, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Osteopathic Association or American Medical Association Continuing Medical Education. One hour of a two hour course which is provided by a facility licensed pursuant to Chapter 395, F.S., for its employees may be used to partially meet this requirement.

(5) Licensure as a Prescribing Physician Assistant. (a) An applicant for licensure as a prescribing physician assistant shall, together with the supervising physician, jointly file the

application for licensure to the Department on a form approved by the Council and Boards and provided by the Department. The same application may be utilized by any alternate supervising physicians, provided that all supervising physicians practice in the same specialty area and in the same practice setting. A separate application form shall be required for each distinct specialty area of practice, as well as for each distinct practice setting. Satellite offices within the same practice do not constitute distinct practices.

(b) The applicant shall have completed a 3 hour course approved by the Board in prescriptive practice, which shall cover the limitations, responsibilities, and privileges involved in prescribing medicinal drugs.

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(c) The applicant shall have completed a minimum of 3 months of clinical experience in the specialty area of the supervising physician. For purposes of this rule, this means 3 continuous months of full-time practice or its equivalent, following full licensure as a physician assistant, within the 4 years immediately preceding the filing of the application.

(d) The fee for licensure as a prescribing Physician Assistant shall be as set forth in Rule 64B15-6.013, F.A.C., and shall be in addition to any other applicable fees in said rule. No additional fees will be required for any separate application for a distinct area of practice, or a change in practice setting during the same biennium.

Specific Authority 458.347(7), 459.005, 459.022 FS. Law Implemented 120.53(1)(a), 456.013, 456.031, 456.033, 459.022 FS. History–New 10-18-77, Formerly 21R-6.03, Amended 10-28-87, 4-21-88, 4-18-89, 9-26-90, 5-20-91, 10-28-91, 3-16-92, Formerly 21R-6.003, Amended 11-4-93, 3-29-94, Formerly 61F9-6.003, Amended 2-1-95, Formerly 59W-6.003, Amended 6-7-98, 3-10-02, 2-23-04.

64B15-6.0031 Change in Employment Status. (1) The supervising physician of any physician assistant who is terminated from employment or otherwise ends employment as

a physician assistant shall notify the Council in writing within 30 days of such occurrence. (2) Each physician assistant shall submit changes to the Department on the form approved by the Council and Boards, and

provided by the Department within 30 days of any change of employment status. (3) Upon any change in employment status the licensed physician assistant’s prescribing privileges shall immediately be

stayed until such time as a new written agreement is entered into pursuant to Rule 64B8-30.007 or 64B15-6.0037, F.A.C., and a new form is filed with the Department.

Specific Authority 458.309, 458.347(13), 459.005, 459.022(13) FS. Law Implemented 458.347, 459.022(7)(d) FS. History–New 10-28-87, Amended 1-3-93, Formerly 21R-6.0031, 61F9-6.0031, 59W-6.0031, Amended 6-7-98, 7-13-03.

64B15-6.0035 Physician Assistant Licensure Renewal and Reactivation. (1) A Physician Assistant must renew his licensure on a biennial basis. Upon request by the Board or Department, the licensee

must submit satisfactory documentation of compliance with the requirements set forth below. (2) Requirements for Renewal. (a) Completion of the Physician Assistant certification renewal application, form PA/REN003, entitled “Affidavit”, effective

11-30-94, which is incorporated herein by reference and available from the Council office. (b) Submission of a signed, sworn statement of no felony convictions in the previous two years. (c) If requested by the Council, the Physician Assistant must submit a notarized copy of a current certificate issued by the

National Commission on Certification of Physician Assistants or must be able to produce evidence that the 100 CME hours have been approved by the American Academy of Physician Assistants and logged with either the American Academy of Physician Assistants or the National Commission of Certification of Physician Assistants for the relevant biennium.

(d) For all licensees no more and no less than one hour shall consist of training in domestic violence which includes information on the number of patients in that professional’s practice who are likely to be victims of domestic violence and the number who are likely to be perpetrators of domestic violence, screening procedures for determining whether a patient has any history of being either a victim or a perpetrator of domestic violence, and instruction on how to provide such patients with information on, or how to refer such patients to, resources in the local community, such as domestic violence centers and other advocacy groups, that provide legal aid, shelter, victim counseling, batterer counseling, or child protection services, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Medical Association Continuing Medical Education. Home study courses approved by the above agencies will be acceptable.

(e) For all licensees one hour of Category I American Medical Association Continuing Medical Education which includes the topics of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome; the modes of transmission, including transmission from healthcare worker to patient and patient to healthcare worker; infection control procedures, including universal precautions; epidemiology of the disease; related infections including TB; clinical management, prevention; and current Florida law on AIDS and its impact on testing, confidentiality of test results, and treatment of patients. Any hours of said CME may also be counted toward the CME license renewal requirements. In order for a course to count as meeting this requirement, licensees practicing in Florida must clearly demonstrate that the course includes Florida law in HIV/AIDS and its impact on testing, confidentiality of test results, and treatment of patients. Only Category I hours shall be accepted.

(f) Notwithstanding the provisions of paragraphs (d) and (e), above, a physician assistant may complete continuing education on end-of-life care and palliative health care in lieu of continuing education in HIV/AIDS or domestic violence, if that physician assistant has completed the HIV/AIDS or domestic violence continuing education in the immediately preceding biennium. This allows for end-of-life care and palliative health care continuing education to substitute for HIV/AIDS or domestic violence continuing education in alternate biennia.

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(g) Completion of two hours of continuing medical education relating to prevention of medical errors which includes a study of root cause analysis, error reduction and prevention, and patient safety, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Medical Association Continuing Medical Education. One hour or a two hour course which is provided by a facility licensed pursuant to Chapter 395, F.S., for its employees may be used to partially meet this requirement.

(3) Renewal of Licensure as a Prescribing Physician Assistant. In addition to the requirements of subsection (2) above, a prescribing physician assistant shall attest to having completed a minimum of 10 hours of continuing education in the specialty area(s) of the supervising physician(s), during the previous 2 years. These hours may be utilized to meet the general continuing education requirement.

(4) Reactivation of Inactive License. To reactivate a license that has been inactive for two (2) consecutive biennial cycles, the licensee must:

(a) Submit to the Department the original inactive license; (b) Provide the Department with licensure verification from each state in which the licensee is licensed to practice as a

physician assistant, or a statement that the licensee is licensed only in Florida; (c) Provide to the Department a statement of medical activities from the date the licensee became inactive to the present; or, if

the licensee has not practiced as a physician assistant for at least 2 of the 4 years preceding application for reactivation, the licensee must:

1. Successfully complete the 16 credit hour Graduate Clerkship offered by Nova Southeastern University (Physician Assistant Department) or an equivalent program approved by the Council; and

2. Practice under the direct supervision of a supervising physician approved by the Council for one (1) year. 3. In lieu of proof of completion of the Graduate Clerkship or the equivalent, the licensee may submit proof of recertification

by NCCPA. (d) Submit to the Department a statement of any criminal or disciplinary actions pending in any jurisdiction; (e) Submit proof of completion of the continuing medical education requirements in compliance with paragraphs

64B15-6.0035(2)(c), (d), (e), (f) and (g), F.A.C., for each biennium in which the license was inactive; (f) Pay the appropriate fees. (5) Licensure Renewal or Reactivation Applications. (a) Application for renewal as a licensed Physician Assistant and as a prescribing Physician Assistant or for reactivation must

be made upon forms supplied by the Council. (b) Renewal or reactivation application forms submitted to the Council must be complete in every detail and must be typed or

printed legibly in black ink. (6) The renewal and reactivation fees are found in Rule 64B8-30.019 or 64B15-6.013, F.A.C. (7) The failure of any license holder to renew the license on or before the license expires shall cause the license to become

delinquent. (a) The delinquent status licensee must apply for active or inactive license status during the licensure cycle in which the license

becomes delinquent. The failure by the delinquent licensee to become active or inactive before the expiration of the licensure cycle in which the license became delinquent shall render the license null and void without further action by the Board or the Department.

(b) The delinquent status licensee who applies for active or inactive licensure shall: 1. File with the Department the completed application for either active or inactive license status; 2. Pay to the Board the applicable license renewal fee, the delinquency fee, and if applicable, the processing fee; and 3. If active status is elected, demonstrate compliance with the continuing education requirements found in Rule 64B15-6.0035,

F.A.C. (8) Licensees who are spouses of members of the Armed Forces of the United States shall be exempt from all licensure renewal

provisions for any period of time which the licensee is absent from the State of Florida due to the spouse’s duties with the Armed Forces. The licensee must document the absence and the spouse’s military status to the Board in order to obtain the exemption. Upon the licensee’s return to Florida, the licensee must inform the Department of his or her return within 30 days.

Specific Authority 456.013, 456.033(1), 459.005, 459.022 FS. Law Implemented 456.013, 456.031, 459.022(7)(b), (c) FS. History–New 10-28-87, Amended 4-21-88, 1-3-93, Formerly 21R-6.0035, Amended 11-4-93, 3-29-94, Formerly 61F9-6.0035, 59W-6.0035, Amended 6-7-98, 10-16-01, 3-10-02, 7-13-04, 7-27-04.

64B15-6.00365 Dispensing Drugs. Only those physician assistants authorized by law and rule to prescribe shall be permitted to dispense sample drugs to patients. Dispensing of sample drugs to patients shall be permitted only when no charge is made to the patient or a third party for the service or the drugs and if the sample being dispensed could otherwise have been legally prescribed by the physician assistant. This rule shall not be construed to prohibit a physician assistant employed in a county health department from ordering and providing patients with prepackaged and prelabeled drugs in accordance with Section 154.04(1)(c), F.S.

Specific Authority 456.033, 459.022 FS. Law Implemented 456.033, 459.022 FS. History–New 5-12-98, Amended 3-26-06.

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64B15-6.0037 Requirements and Limitations of Prescribing Privileges. Written prescriptions shall be subject to the following requirements: Each supervising physician and prescribing physician assistant shall enter into and keep on file a written agreement outlining which medicinal drugs not prohibited by the formulary the supervising osteopathic physician has specifically authorized the physician assistant to prescribe. Each agreement must be signed and dated by all parties and maintained on file for at least five (5) years. Any such agreement must be provided to the Department, the Council, or any of their agents upon request.

Specific Authority 459.022 FS. Law Implemented 459.022 FS. History–New 2-20-94, Formerly 61F9-6.0037, Amended 2-1-95, Formerly 59W-6.0037, Amended 5-12-98, 2-23-04.

64B15-6.0038 Formulary. (1) PHYSICIAN ASSISTANTS APPROVED TO PRESCRIBE MEDICINAL DRUGS UNDER THE PROVISIONS OF

SECTION 458.347(4)(e) OR 459.022 (4)(e), F.S., ARE NOT AUTHORIZED TO PRESCRIBE THE FOLLOWING MEDICINAL DRUGS, IN PURE FORM OR COMBINATION:

(a) Controlled substances, as defined in Chapter 893, F.S.; (b) Antipsychotics; (c) General, spinal or epidural anesthetics; (d) Radiographic contrast materials; (e) Any parenteral preparation except insulin and epinephrine. Parenteral includes: intravenous, subcutaneous, intramuscular,

and any route other than the alimentary canal; however, it does not include topical or mucosal application. Nothing in this formulary prohibits a physician assistant from administering a parenteral drug under the direction or supervision of the supervising physician.

(2) A supervising physician may delegate to a prescribing physician assistant only such authorized medicinal drugs as are used in the supervising physician’s practice, not listed in subsection (1).

(3) Subject to the requirements of this subsection, Sections 458.347 and 459.022, F.S., and the rules enacted thereunder, drugs not appearing on this formulary may be delegated by a supervising physician to a prescribing physician assistant to prescribe.

(4) Nothing herein prohibits a supervising physician from delegating to a physician assistant the authority to order medicinal drugs for a hospitalized patient of the supervising physician, nor does anything herein prohibit a supervising physician from delegating to a physician assistant the administration of a medicinal drug under the direction and supervision of the physician.

Specific Authority 458.347, 459.022(4)(e) FS. Law Implemented 459.022(4)(e) FS. History–New 3-12-94, Formerly 61F9-6.0038, Amended 11-30-94, 4-17-95, 8-27-95, 11-13-96, Formerly 59W-6.0038, Amended 5-12-98, 3-10-99, 3-9-00, 6-19-00, 11-23-00, 2-26-02, 2-23-04.

64B15-6.004 Requirements for Approval of Training Programs. (1) Any Physician Assistant program wishing to be approved and recognized by the State of Florida must maintain

accreditation with the Commission on Accreditation on Allied Health Education Programs or its successor, or have been accredited by the Committee on Allied Health, Education, and Accreditation. For those allopathic Physician Assistant training programs graduating Physician Assistants prior to February 1973, any graduate is deemed eligible to be licensed as a Physician Assistant in the State of Florida, provided the graduate has been recognized by the National Commission on Certification of Physician Assistants as a formally trained Physician Assistant. For those osteopathic Physician Assistant training programs graduating Physician Assistants prior to 1974, any graduate is deemed eligible to be licensed as a Physician Assistant in the State of Florida, provided the graduate has been recognized by the National Commission on Certification of Physician Assistants as a formally trained Physician Assistant.

(2) The Council shall maintain a list of all accredited programs published by the Commission on Accreditation on Allied Health Education Programs or its successor or Committee on Allied Health, Education, and Accreditation.

Specific Authority 458.347, 459.022(6) FS. Law Implemented 458.347, 459.022(6) FS. History–New 10-18-77, Formerly 21R-6.04, Amended 10-28-87, 3-16-92, Formerly 21R-6.004, 61F9-6.004, Amended 2-1-95, Formerly 59W-6.004, Amended 6-7-98, 3-17-99.

64B15-6.006 Advertising. (1) Advertising by physician assistants is permitted so long as such information is in no way false, deceptive, or misleading. (2) Physician assistant advertisements shall disclose the name of the primary supervising physician of the physician assistant

advertising his or her services. (3) Physician assistants may not claim any type of specialty board certification. (4) Only physician assistants certified by the National Commission on Certification of Physician Assistants (NCCPA) may

claim certification and employ the abbreviation “PA-C” next to his or her name. (5) Failure to abide by the provisions of this rule shall constitute a violation of Sections 459.015(1)(d) and (pp) and

456.072(1)(cc), F.S.

Specific Authority 459.022(13) FS. Law Implemented 459.015(1)(d), 459.022(7)(f) FS. History–New 4-26-04.

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64B15-6.010 Physician Assistant Performance. (1) A supervising physician shall delegate only tasks and procedures to the physician assistant which are within the supervising

physician’s scope of practice. The physician assistant may work in any setting that is within the scope of practice of the supervising physician’s practice. The supervising physician’s scope of practice shall be defined for the purpose of this section as “those tasks and procedures which the supervising physician is qualified by training or experience to perform.”

(2) The decision to permit the physician assistant to perform a task or procedure under direct or indirect supervision is made by the supervising physician based on reasonable medical judgment regarding the probability of morbidity and mortality to the patient. Furthermore, the supervising physician must be certain that the physician assistant is knowledgeable and skilled in performing the tasks and procedures assigned.

(a) The following duties are not permitted to be delegated at all except where expressly authorized by statute: 1. Prescribing, dispensing, or compounding medicinal drugs; 2. Final diagnosis. (b) The following duties are not to be performed under indirect supervision: 1. Routine insertion of chest tubes and removal of pacer wires or left atrial monitoring ring lines; 2. Performance of cardiac stress testing; 3. Routine insertion of central venous catheters; 4. Injection of intrathecal medication without prior approval of the supervising physician; 5. Interpretation of laboratory tests, X-ray studies and EKG’s without the supervising physician’s interpretation and final

review; 6. Administration of general, spinal, and epidural anesthetics; this may be performed under direct supervision only by

physician assistants who graduated from Board-approved programs for the education of anesthesiology assistants. (3) All tasks and procedures performed by the physician assistant must be documented in the appropriate medical record.

During the initial six months of supervision of each physician assistant all documentation by the physician assistant in a medical chart must be reviewed, signed and dated by a supervising physician within seven days. Subsequent thereto, a supervising physician must review, sign and date all documentation by a physician assistant in medical charts within 30 days.

(4) In a medical emergency the physician assistant will act in accordance with his or her training and knowledge to maintain life support until a licensed physician assumes responsibility for the patient.

Specific Authority 459.005, 459.022(4)(a), (13) FS. Law Implemented 459.022(2), (3), (4), (13) FS. History–New 10-28-87, Amended 4-18-89, 9-26-90, Formerly 21R-6.010, 61F9-6.010, Amended 3-13-96, Formerly 59W-6.010, Amended 10-13-98, 3-17-99, 1-12-04.

64B15-6.0105 Notice of Noncompliance. (1) Pursuant to Section 456.073(3), F.S., the Department is authorized to provide a notice of noncompliance for an initial

offense of a minor violation if the Board establishes by rule a list of minor violations. A minor violation is one which does not endanger the public health, safety, and welfare and which does not demonstrate a serious inability to practice the profession. A notice of noncompliance in lieu of other action is authorized only if the violation is not a repeat violation and only if there is only one violation. If there are multiple violations, then the Department may not issue a notice of noncompliance, but must prosecute the violations under the other provisions of Section 456.073, F.S. A notice of noncompliance may be issued to a licensee for a first time violation of one or both of the violations listed in paragraph (3)(b). Failure of a licensee to take action in correcting the violation within 15 days after notice shall result in the institution of regular disciplinary proceedings.

(2) The Department shall submit to the Board a monthly report detailing the number of notices given, the number of cases completed through receipt of a notarized statement of compliance from the licensee, and the types of violations for which notices of noncompliance have been issued. Notices of noncompliance shall be considered by the probable cause panels when reviewing a licensee’s subsequent violations of a same or similar offense.

(3) The following violations are those for which the board authorizes the Department to issue a notice of noncompliance: (a) Failing to include the specific disclosure statement required by Section 456.062, F.S., in any advertisement for a free,

discounted fee, or reduced fee service, examination or treatment. (b) Violating any of the following provisions of Chapter 459, F.S., as prohibited by Sections 459.022(7)(f) and 459.015(1)(bb),

F.S.: 1. Section 459.022(1), F.S., which provides for criminal penalties for the practice as a physician assistant without an active

license. A notice of noncompliance would be issued for this violation only if the subject of the investigation met the following criteria: the subject was the holder of a license to practice as a physician assistant at all time material to the matter; that license was otherwise in good standing; and that license was or will be renewed and placed in an active status within 90 days of the date it reverted to delinquent status based on failure to renew the license. If the license was in a delinquent status for more than 90 days and the individual continued to practice, then the matter would proceed under the other provisions of Sections 456.073 and 456.035(1), F.S.

2. Failing to notify the Board of a change of practice location, contrary to Sections 459.008(3) and 456.035(1), F.S. 3. Failure to timely notify the Department of a change of supervision (addition or deletion of a supervisor (Section

459.022(7)(d), (f), F.S.).

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Specific Authority 456.073(3), 459.005, 459.022(7)(f), (12) FS. Law Implemented 456.073(3), 458.347(7)(f), (12), 459.015 FS. History–New 3-10-02, Amended 8-2-06.

64B15-6.01051 Citation Authority. In lieu of the disciplinary procedures contained in Section 456.073, F.S., the offenses enumerated in this rule may be disciplined by the issuance of a citation. The citation shall include a requirement that the licensee correct the offense, if possible, within a specified period of time, impose whatever obligations will correct the offense, and impose the prescribed penalty.

(1) Pursuant to Section 456.077, F.S., the Board sets forth below those violations for which there is no substantial threat to the public health, safety, and welfare; or, if there is a substantial threat to the public health, safety, and welfare, such potential for harm has been removed prior to the issuance of the citation. Next to each violation is the penalty to be imposed. In addition to any administrative fine imposed, the Respondent may be required by the Department to pay the costs of investigation.

(2) If the violation constituted a substantial threat to the public health, safety, and welfare, such potential for harm must have been removed prior to issuance of the citation.

(3) The following violations with accompanying penalty may be disposed of by citation with the specified penalty:

VIOLATIONS PENALTY (a) CME violations. Within twelve months of the date the citation is issued, (Sections 459.022(7)(b), 459.015(1)(g), (bb), Respondent must submit certified documentation of 456.072(1)(e), (s), F.S.) completion of all CME requirements for the period for

which the citation was issued; prior to renewing the license for the next biennium, Respondent must document compliance with the CME requirements for the relevant period; AND pay a $250 fine.

1. Failure to document required HIV/AIDS CME. $250 fine (Section 456.033, F.S.)

2. Failure to document required domestic violence, or $250 fine end-of-life and palliative health care CME. (Section 456.031, F.S.)

3. Failure to document required prevention of medical $250 fine errors CME.

4. Failure to document both the required HIV/AIDS and $500 fine domestic violence, or end-of-life and palliative health care CME.

5. Failure to document required prevention of medical $250 fine errors CME. (Section 456.013(7), F.S.)

6. Documentation of some, but not all, 100 hours of $25 fine for each hour not documented required CME for license renewal.

(b) Obtaining license renewal by negligent $2500 fine misrepresentation. (Sections 459.022(7)(f) and 459.015(1)(a), F.S.)

(c) Failure to document any of the 100 hours of required $2500 fine CME for license renewal. (Sections 459.022(7)(b) and 459.015(1)(bb), F.S.)

(d) Practice on an inactive or delinquent license. (Sections 456.036(1), 459.013(1)(a), 459.022(7)(f) and 459.015(1)(bb), F.S.)

1. For a period of up to nine months. $100 for each month or part thereof.

2. For a period of nine months to twelve months. $150 for each month or part thereof.

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(e) Failure to notify Department of change of practice and/ $125 fineor mailing address.(Sections 456.035, 459.008(3), 459.015(1)(g),459.022(7)(f), F.S.)

(f) Failure of the physician assistant to clearly identify $250 finethat he/she is a physician assistant.(Sections 459.022(4)(e)1., 459.022(7)(f),459.015(1)(g), F.S.)

(g) Second failure to report to the Department of addition/ $250 fine per supervising physiciandeletion/change of supervising physician(s) within 30 daysafter the change is made.(Sections 456.035, 459.015(1)(g),459.022(7)(d), (f), F.S.)

(h) Failure to notify the Board in writing within 30 days if $500 finean action as defined in Section 459.015(1)(b), F.S., hasbeen taken against one’s license to practice as a physicianassistant in another state, territory, or country if that actionwas based on action taken by the Florida Board ofOsteopathic Medicine.(Section 456.072(1)(w), F.S.)

(i) First time failure to pay fine or costs imposed by Board $500 fineOrder within 30 days of the due date of the fine or costs.(Failure to pay more than 30 days after the due date willresult in an administrative complaint.)(Section 456.072(1)(q), F.S.)

(4) Citations shall be issued to licensees by the Bureau of Investigative Services only after review by the legal staff of the Department.

(5) The Department of Health shall, at the end of each calendar quarter, submit a report to the Board of the citations issued, which report shall contain the name of the subject, the violation, fine imposed, and the number of subjects who dispute the citation and chose to follow the procedures of Section 456.073, F.S.

Specific Authority 456.077, 459.005, 459.022(7)(f), (12) FS. Law Implemented 456.077, 459.015, 459.022(7)(d), (f), (12) FS. History–New 3-10-02, Amended 1-12-04, 5-4-04, 12-12-05, 8-2-06.

64B15-6.011 Disciplinary Guidelines. (1) Purpose. Pursuant to Section 456.072, F.S., the Boards provide within this rule disciplinary guidelines which shall be

imposed upon physician assistant applicants or licensees whom it regulates under Chapters 458 and 459, F.S. The purpose of this rule is to notify such applicants and licensees of the ranges of penalties which will routinely be imposed unless the Boards find it necessary to deviate from the guidelines for the stated reasons given within this rule. The ranges of penalties provided below are based upon a single count violation of each provision listed; for multiple counts of the violated provisions or a combination of the violations the Boards shall consider a higher penalty than that for a single, isolated violation. Each range includes the lowest and highest penalty and all penalties falling between. The purposes of the imposition of discipline are to punish the applicants or licensees for violations and to deter them from future violations; to offer opportunities for rehabilitation, when appropriate; and to deter other applicants or licensees from violations.

(2) Violations and Range of Penalties. In imposing discipline upon physician assistant applicants and licensees, in proceedings pursuant to Sections 120.57(1) and (2), F.S., the Board shall act in accordance with the following disciplinary guidelines and shall impose a penalty within the range corresponding to the violations set forth below. The verbal identification of offenses are descriptive only; the full language of each statutory provision cited must be consulted in order to determine the conduct included.

VIOLATIONS RECOMMENDED PENALTIES

First Offense Subsequent Offenses

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(a) Attempting to obtain a license orcertificate by bribery, fraud or throughan error of the Department or theBoard.(Section 459.015(1)(a), F.S.);(Section 456.072(1)(h), F.S.)

(b) Action taken against license byanother jurisdiction.(Section 459.015(1)(b), F.S.);(Section 456.072(1)(f), F.S.)

1. Action taken against license by another jurisdiction relating tohealthcare fraud in dollar amounts in excess of $5,000.00.

2. Action taken against license by another jurisdiction relating tohealthcare fraud in dollar amounts of$5,000.00 or less.

(c) Guilt of crime directly relating to practice or ability to practice.(Section 459.015(1)(c), F.S.);(Section 456.072(1)(c), F.S.)

1. Involving a crime directly related to healthcare fraud in dollar amounts in excess of $5,000.00.

2. Involving a crime directly related to healthcare fraud in dollar amounts of$5,000.00 or less.

(d) False, deceptive, or misleadingadvertising.(Section 459.015(1)(d), F.S.)

(a) From suspension of license to revocation, with ability to reapply, or denial of licensure.

(b) From imposition of discipline comparable to the discipline which would have been imposed if the substantive violation had occurred in Florida to reprimand through suspension or denial of the license until the license is unencumbered in the jurisdiction in which disciplinary action was originally taken and an administrative fine ranging from $1,000.00 to $2,500.00.

1. From revocation with leave to reapply in three (3) years, and an administrative fine ranging from $2,500.00 to $5,000.00, or in the case of application for licensure, denial of licensure.

2. From an administrative fine ranging from $1,000.00 to $5,000.00, and a reprimand through suspension of the license, or in the case of application for licensure, denial of licensure.

(c) From reprimand to revocation or denial of license, and an administrative fine of $1,000.00 to $5,000.00.


2. From an administrative fine ranging from $1,000.00 to $5,000.00, and a reprimand through suspension of the license, or in case of application for licensure, denial of licensure.

(d) From a letter of concern to reprimand, or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

(a) From denial of license to revocation of license with ability to reapply in not less than three years and a fine up to $5,000.00 to denial of license without ability to reapply.

(b) From imposition of discipline comparable to the discipline which would have been imposed if the substantive violation had occurred in Florida to suspension and revocation or denial of the license until the license is unencumbered in the jurisdiction in which disciplinary action was originally taken, and an administrative fine ranging from $2,500.00 to $5,000.00.

1. From permanent revocation and an administrative fine ranging from $2,500.00 to $5,000.00, or in the case of application for licensure, denial of licensure.

2. From an administrative fine ranging from $2,500.00 to $5,000.00, and suspension of the license, followed by a period of probation to revocation, or in the case of application for licensure, denial of licensure.

(c) From probation to revocation or denial of the license, and an administrative fine ranging from $2,500.00 to $5,000.00.


2. From an administrative fine ranging from $2,500.00 to $5,000.00, and suspension of the license, followed by a period of probation to revocation, or in case of application for licensure, denial of licensure.

(d) From a letter of concern to reprimand or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

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(e) Failure to report another licenseein violation.(Section 459.015(1)(e), F.S.);(Section 456.072(1)(i), F.S.)

(f) Aiding unlicensed practice.(Section 459.015(1)(f), F.S.);(Section 456.072(1)(j), F.S.)

(g) Failure to perform legal obligation.(Section 459.015(1)(g), F.S.);(Section 456.072(1)(k), F.S.)

1. Continuing medical education(CME) violations.(Section 456.072(1)(e), F.S.);(Section 456.072(1)(s), F.S.);(Section 456.033(9), F.S.)

a. Failure to document required HIV/AIDS, or end of life care, or palliativehealth care.

b. Failure to document requireddomestic violence CME or substituteend-of-life-care CME.

c. Failure to document required HIV/AIDS, or end-of-life-care, or palliativehealth care, and failure to documentdomestic violence CME.

2. Failing to report to the Board within30 days after the licensee has beenconvicted of a crime in anyjurisdiction.(Section 456.072(1)(w), F.S.)Or failing to report to the Boardconvictions prior to the enactment ofthis section, in writing, on or beforeOctober 1, 1999.(Section 456.072(1)(w), F.S.)

3. Failing to disclose financial interestto patient.(Section 456.052, F.S.)

(h) Giving false testimony in a legal oradministrative proceeding.(Section 459.015(1)(h), F.S.)

(e) From a letter of concern to probation and an administrative fine ranging from $1,000.00 to $2,500.00, or denial of licensure.

(f) From reprimand to suspension, followed by probation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(g) For any offense not specifically listed herein, based upon the severity of the offense and the potential for patient harm, from a reprimand to revocation or denial of licensure and an administrative fine from $1,000.00 to $5,000.00.

1. Document compliance with the CME requirements for the relevant period; AND:

a. An administrative fine ranging from $250.00 to $500.00.

b. An administrative fine ranging from $250.00 to $500.00.

c. An administrative fine ranging from $500.00 to $1,000.00.

2. From an administrative fine ranging from $1,000.00 to $5,000.00 and a reprimand or denial of licensure, with the ability to reapply.

3. A refund of fees paid by or on behalf of the patient and from an administrative fine of $1,000.00 to a reprimand and an administrative fine of $2,500.00.

(h) From a reprimand, or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

(e) From reprimand to suspension or denial of licensure, and an administrative fine from $2,500.00 to $5,000.00.

(f) From probation to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(g) For any offense not specifically listed herein, based upon the severity of the offense and the potential for patient harm, from a reprimand to revocation or denial and an administrative fine from $2,500.00 to $5,000.00.

1. Document compliance with the CME requirements for the relevant period; AND:

a. An administrative fine ranging from $500.00 to $1,000.00.

b. An administrative fine of $500.00 to $1,000.00.

c. An administrative fine ranging from $1,000.00 to $2,000.00.

2. From an administrative fine ranging from $2,500.00 to $5,000.00 and a reprimand or denial of licensure, without the ability to reapply.

3. A refund of fees paid by or on behalf of the patient and from a reprimand and an administrative fine of $2,500.00 to a reprimand and an administrative fine of $5,000.00.

(h) From probation to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

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(i) Filing a false report or failing tofile a report as required.(Section 459.015(1)(i), F.S.);(Section 456.072(1)(l), F.S.)

1. Relating to healthcare fraud indollar amounts in excess of $5,000.00.

2. Relating to healthcare fraud indollar amounts of $5,000.00 or less.

(j) Kickbacks or split feearrangements.(Section 459.015(1)(j), F.S.)

(k) Improper refusal to providehealthcare.(Section 459.015(1)(k), F.S.)

(l) Sexual Misconduct.(Section 459.015(1)(l), F.S.);(Section 456.072(1)(u), F.S.)

(m) Deceptive, untrue, or fraudulentrepresentations in the practice ofosteopathic medicine.(Section 459.015(1)(m), F.S.);(Sections 456.072(1)(a), (m), F.S.)

1. Deceptive, untrue, or fraudulentrepresentations in the practice ofosteopathic medicine relating tohealthcare fraud in dollar amounts in excess of $5,000.00.

2. Deceptive, untrue, or fraudulentrepresentations in the practice ofosteopathic medicine relating tohealthcare fraud in dollar amounts of$5,000.00 or less.

(i) From a letter of concern to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.



(j) A refund of fees paid by or on behalf of the patient from a reprimand and an administrative fine of $1,000.00 to a reprimand and an administrative fine of $5,000.00, or denial of licensure.

(k) From a letter of concern, and an administrative fine of $1,000.00 to a letter of concern and an administrative fine of $2,500.00, or denial of licensure.

(l) From probation to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(m) From a letter of concern to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.



(i) From probation to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.



(j) A refund of fees paid by or on behalf of the patient from suspension to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(k) From a reprimand to probation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(l) From suspension to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(m) From probation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00 to revocation.



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(n) Improper solicitation of patients. (Section 459.015(1)(n), F.S.)

(o) Failure to keep legible writtenmedical records.(Section 459.015(1)(o), F.S.)

1. Failure to keep legible writtenmedical records relating to healthcarefraud in dollar amounts in excess of$5,000.00.

2. Failure to keep legible writtenmedical records relating to healthcarefraud in dollar amounts of $5,000.00or less.

(p) Fraudulent alteration ordestruction of patient records.(Section 459.015(1)(p), F.S.)

(q) Exercising influence on patient forfinancial gain. (Section 459.015(1)(q), F.S.);(Section 456.072(1)(n), F.S.)

(r) Improper advertising of pharmacy.(Section 459.015(1)(r), F.S.)

(s) Performing professional servicesnot authorized by patient. (Section459.015(1)(s), F.S.)

(t) Inappropriate or excessiveprescribing.(Section 459.015(1)(t), F.S.)

(u) Prescribing, dispensing,administering of a scheduled drug bythe physician assistant to himself orherself.(Section 459.015(1)(u), F.S.)

(n) From an administrative fine ranging from $1,000.00 to $5,000.00, and a reprimand to probation, or denial of licensure.

(o) From letter of concern to a reprimand, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.



(p) From a reprimand to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(q) Payment of fees paid by or on behalf of the patient and from a reprimand to probation, or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(r) From a letter of concern to probation, or a denial of licensure, and an administrative fine ranging from $250.00 to $2,500.00.

(s) From a letter of concern to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(t) From reprimand to probation and an administrative fine ranging from $1,000.00 to $5,000.00, or denial of licensure.

(u) From probation to suspension or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

(n) From suspension to revocation or denial of licensure, and an administrative fine from $2,500.00 to $5,000.00.

(o) From a reprimand to suspension followed by probation, and an administrative fine ranging from $2,500.00 to $5,000.00, or denial of licensure.



(p) From probation to revocation, or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(q) Payment of fees paid by or on behalf of the patient and from probation to suspension, or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(r) From a reprimand and an administrative fine of $2,500.00 to probation, and an administrative fine from $2,500.00 to $5,000.00, or denial of licensure.

(s) From a reprimand to revocation, or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(t) From probation to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(u) From suspension to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

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(v) Use of amygdalin (laetrile). (Section 459.015(1)(v), F.S.)

(w) Inability to practice osteopathic medicine with skill and safety. (Section 459.015(1)(w), F.S.)

(x)1. Malpractice: practicing below acceptable standard of care. (Section 459.015(1)(x), F.S.)

2. Gross Malpractice

3. Repeated Malpractice

(y) Performing of experimental treatment without informed consent. (Section 459.015(1)(y), F.S.)

(z) Practicing beyond scope permitted. (Section 459.015(1)(z), F.S.)

(aa) Delegation of professionalresponsibilities to unqualified person.(Section 459.015(1)(aa), F.S.);(Section 456.072(1)(p), F.S.)

(bb)1. Violation of law, rule, or failureto comply with subpoena.(Section 459.015(1)(bb), F.S.);(Sections 456.072(1)(b), (q), F.S.)

2. Violation of an order of the Board.

(v) From a reprimand to probation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

(w) From reprimand to suspension, which may be stayed to allow a period of probation with supervision, and a demonstration by the licensee of the ability to practice with reasonable skill and safety, or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

(x)1. From a letter of concern to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

2. From a probation to revocation or denial of licensure, and an administrative fine ranging from $1,000.00 to $2,500.00.

3. From a reprimand to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(y) From a letter of concern to suspension, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00

(z) From a letter of concern to reprimand and probation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(aa) From reprimand to suspension, followed by probation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

(bb)1. For any offense not specifically listed herein, based upon the severity of the offense and the potential for patient harm, from a reprimand to revocation, or denial of licensure, and an administrative fine ranging from $1,000.00 to $5,000.00.

2. From a letter of concern and an administrative fine of $1,000.00 to a letter of concern and an administrative fine of $5,000.00.

(v) From suspension to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(w) From probation to revocation, until the licensee is able to demonstrate ability to practice with reasonable skill and safety, followed by probation, or denial of licensure, and an administrative fine from $2,500.00 to $5,000.00.

(x)1. From reprimand to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

2. From suspension followed by probation to revocation or denial, and an administrative fine ranging from $2,500.00 to $5,000.00.

3. From probation to revocation or denial of licensure, and an administrative fine from $2,500.00 to $5,000.00.

(y) From suspension to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(z) From probation to suspension or revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(aa) From probation to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(bb)1. From probation to revocation or denial of licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

2. From a reprimand and an administrative fine of $2,500.00 to a reprimand and an administrative fine of $5,000.00 and probation.

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(cc) Conspiring to restrict another (cc) From a letter of concern to a (cc) From a reprimand and an from lawfully advertising services. reprimand and an administrative fine administrative fine of $2,500.00 to a (Section 459.015(1)(cc), F.S.) ranging from $1,000.00 to $2,500.00. reprimand and an administrative fine of

$5,000.00.

(dd) Aiding an unlawful abortion. (dd) From probation to revocation, or (dd) From suspension to revocation or (Section 459.015(1)(dd), F.S.) denial of licensure, and an denial of licensure, and an administrative

administrative fine ranging from fine ranging from $2,500.00 to $5,000.00. $1,000.00 to $5,000.00.

(ee) Presigning prescription forms. (ee) From a letter of concern to a (ee) From a reprimand to probation, and an (Section 459.015(1)(ee), F.S.) reprimand and an administrative fine administrative fine ranging from $2,500.00

of $1,000.00 to a letter of concern and to $5,000.00. an administrative fine of $2,500.00.

(ff) Improperly interfering with an (ff) From a reprimand to probation, or (ff) From probation to revocation or denial investigation or a disciplinary denial of licensure, and an of licensure without ability to re-apply, and procedure. administrative fine ranging from an administrative fine ranging from (Section 459.015(1)(kk), F.S.); $1,000.00 to $2,500.00. $2,500.00 to $5,000.00. (Section 456.072(1)(r), F.S.)

(gg) Failing to report any M.D., D.O., (gg) From a letter of concern to (gg) From probation to revocation or denial or PA, who is in violation of law. probation, or denial of licensure, and of licensure, and an administrative fine (Section 459.015(1)(ll), F.S.); an administrative fine ranging from ranging from $2,500.00 to $5,000.00. (Section 456.072(1)(i), F.S.) $1,000.00 to $2,500.00.

(hh) Failure to adequately supervise (hh) From a reprimand to probation, or (hh) From probation to suspension assisting personnel. denial of licensure, and an followed by probation, or denial of (Section 459.015(1)(hh), F.S.) administrative fine ranging from licensure, and an administrative fine

$1,000.00 to $2,500.00. ranging from $2,500.00 to $5,000.00.

(ii) Improper use of substances for (ii) From a reprimand to suspension, (ii) From suspension to revocation or denial muscle building or enhancement of or denial of licensure, and an of licensure, and an administrative fine performance. administrative fine ranging from ranging from $1,000.00 to $5,000.00. (Section 459.015(1)(ii), F.S.) $1,000.00 to $5,000.00.

(jj) Misrepresenting or concealing a (jj) From a reprimand to probation, (jj) From probation to revocation or denial material fact during disciplinary or and an administrative fine ranging of licensure without the ability to reapply, licensure procedure. from $500.00 to $2,500.00, or the and an administrative fine ranging from (Section 459.015(1)(jj), F.S.) denial of licensure with the ability to $500.00 to $5,000.00.

reapply, upon payment of a $500.00 fine.

(kk) Providing medical opinion on (kk) From a letter of concern to a (kk) From probation to revocation or denial claim without reasonable reprimand, or denial of licensure, and of licensure, and an administrative fine investigation. an administrative fine ranging from from $2,500.00 to $5,000.00. (Section 459.015(1)(mm), F.S.) $1,000.00 to $2,500.00.

(ll) Theft or reproduction of an (ll) Suspension to revocation, or denial (ll) Revocation or denial of licensure examination. of licensure without an ability to without ability to reapply. (Section 456.018, F.S.) reapply.

(3) Aggravating and Mitigating Circumstances. Based upon consideration of aggravating and mitigating factors present in an individual case, the Board may deviate from the penalties recommended above. The Board shall consider as aggravating or mitigating factors the following.

(a) Exposure of patients or public to injury or potential injury, physical or otherwise; none, slight, severe, or death; (b) Legal status at the time of the offense; no restraints, or legal constraints; (c) The number of counts or separate offenses established;

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(d) The number of times the same offense or offenses have previously been committed by the licensee or applicant; (e) The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice; (f) Pecuniary benefit or self-gain inuring to the applicant or licensee; (g) Any other relevant mitigating factors. (4) The certification of a Physician Assistant shall be disciplined by the Board when, after due notice and a hearing in

accordance with the provisions of this rule, it shall find: that the Physician Assistant has held himself out or permitted another to represent him as a licensed physician. If any person addresses the Physician Assistant in a medical setting as “Doctor,” the Physician Assistant must immediately inform that person that the Physician Assistant is not a doctor. Upon a finding by the Board of failure to immediately inform the person, the following penalty shall be imposed: a letter of concern, a reprimand, a 60-day suspension and/or a fine up to $2,500.00; and for any subsequent offense, a fine up to $5,000.00 and/or revocation of the certificate.

Specific Authority 456.079, 459.0015, 459.015(5) FS. Law Implemented 456.072, 456.079, 459.015(5), 459.022(4)(e)1., (7)(f) FS. History–New 4-18-89, Formerly 21R-6.011, Amended 11-4-93, Formerly 61F9-6.011, 59W-6.011, Amended 6-7-98, 4-9-01, 7-13-03.

64B15-6.013 Physician Assistant Fees. The following fees are prescribed by the Council and adopted by the Boards:

(1) The application fee for a person applying to be certified as a physician assistant shall be $100. (2) The initial certification fee for any person who is issued a physician assistant certificate as provided in Section 458.347 or

459.022, F.S., shall be $200.00. (3) All persons obtaining certification or re-certification as a physician assistant shall pay an unlicensed activity fee of $5.00 in

addition to the fee in Rule 64B15-6.013, F.A.C. (4) The application fee for a person applying to be certified as a prescribing physician assistant shall be $200.00. The fee for

initial certification as a prescribing physician assistant shall be $200.00. The renewal fee for a prescribing physician assistant shall be $150.00. No additional fees will be required for any separate application for a distinct area of practice or a change in practice setting during the same biennium.

(5) The biennial renewal fee for an active or inactive physician assistant certified pursuant to Section 458.347 or 459.022(7), F.S., shall be $150.00. Certificates not renewed at the end of a biennial period shall automatically become delinquent.

(6) The reactivation fee for an inactive physician assistant certification pursuant to Section 458.347(7) or 459.022(7), F.S., shall be $100. Reactivation shall require payment of all the applicable renewal fees and the reactivation fee.

(7) The duplicate certification fee shall be $25.00. (8) Any certified physician assistant who fails to renew his/her certification by the end of the biennium shall pay a delinquent

fee of $100.00 upon application for either active or inactive status. (9) The fee for processing any changes in the certification status at any time other than the biennial renewal period shall be

$100.00.

Specific Authority 456.036(5), (7), 459.005, 459.009, 459.022(7) FS. Law Implemented 456.036(5), (7), 459.009, 459.022(7) FS. History–New 11-4-93, Amended 2-20-94, Formerly 61F9-6.013, 59W-6.013, Amended 8-11-98, 2-23-04, 7-27-04, 12-6-04.

64B15-6.014 Mediation. (1) For purposes of Section 456.078, F.S., the Board designates as being appropriate for mediation, violations of the following

provisions: (a) Failing to comply with the requirements of Sections 381.026 and 381.0261, F.S., to provide patients with information about

their patient rights and how to file a patient complaint; (b) Negligently failing to file a report or record required by state or federal law; (c) Failing to comply with the requirements for profiling and credentialing. (2) The above-outlined provisions shall qualify for mediation only when the violation can be remedied by the licensee, there is

no allegation of intentional misconduct, no patient injury, and allegations do not involve any “adverse incidents” as defined by Section 456.078(2), F.S.

Specific Authority 456.078 FS. Law Implemented 456.078 FS. History–New 11-30-05.

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CHAPTER 64B15-7 ANESTHESIOLOGIST ASSISTANTS

64B15-7.002 Examination for Licensure. 64B15-7.003 Application for Licensure and Licensure Requirements for Anesthesiologist Assistants. 64B15-7.004 Requirements for Approval of Training Programs. 64B15-7.005 Anesthesiologist Assistant Protocols and Performance. 64B15-7.006 Financial Responsibility. 64B15-7.007 Anesthesiologist Assistant Licensure Renewal and Reactivation. 64B15-7.008 Notice of Noncompliance. 64B15-7.009 Citation Authority. 64B15-7.010 Disciplinary Guidelines. 64B15-7.011 Mediation. 64B15-7.012 Fees Regarding Anesthesiologist Assistants.

64B15-7.002 Examination for Licensure. The Board hereby approves the examination administered through the National Commission on Certification of Anesthesiologist Assistants (NCCAA) as the proficiency examination required for licensure as an anesthesiologist assistant.

Specific Authority 459.005, 459.023 FS. Law Implemented 459.023 FS. History–New 8-2-05.

64B15-7.003 Application for Licensure and Licensure Requirements for Anesthesiologist Assistants. (1) Application for Licensure. (a) All persons applying for licensure as an anesthesiologist assistant shall submit an application to the Department on forms

approved by Boards and provided by the Department. (b) The application may not be used for more than one year from the date of original submission of the application and fee.

Fees are found in Rule 64B15-7.012, F.A.C. After one year from the date that the original application and fee have been received in the Board office, a new application and fee shall be required from any applicant who desires licensure as an anesthesiologist assistant.

(c) All application information must be submitted no later than 15 days prior to the meeting at which the applicant desires his or her application to be considered.

(2) Requirements for Licensure. (a) All applicants for licensure as an anesthesiologist assistant must submit an application as set forth in subsection (1) above.

Applicants must provide a sworn statement of any prior felony convictions and a sworn statement of any prior discipline or denial of licensure or certification in any state. The applicant must meet all of the requirements of Section 459.023, F.S., and the applicant must submit two personalized and individualized letters of recommendation from anesthesiologists. Letters of recommendation must be composed and signed by the applicant’s supervising anesthesiologist, or, for recent graduates, the faculty anesthesiologist, and give details of the applicant’s clinical skills and ability. Each letter must be addressed to the Board and must have been written no more than six months prior to the filing of the application for licensure.

(b) The applicant must have obtained a passing score on the examination administered through the NCCAA. The passing score shall be established by the NCCAA.

(c) The applicant must be certified in advanced cardiac life support. (d) The applicant must provide documentation of the following: 1. Completion of three hours of all Category I, American Medical Association Continuing Medical Education or American

Osteopathic Association approved Category I-A continuing education related to the practice of osteopathic medicine or under osteopathic auspices which includes the topics of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome: the disease and its spectrum of clinical manifestations; epidemiology of the disease; related infections including TB; treatment, counseling, and prevention; clinical management; transmission from healthcare worker to patient and patient to healthcare worker; universal precautions and isolation techniques; and legal issues related to the disease. If the applicant has not already completed the required continuing medical education, upon submission of an affidavit of good cause, the applicant will be allowed six months to complete this requirement.

2. Completion of one hour of continuing medical education on domestic violence which includes information on the number of patients in that professional’s practice who are likely to be victims of domestic violence and the number who are likely to be perpetrators of domestic violence, screening procedures for determining whether a patient has any history of being either a victim or a perpetrator of domestic violence, and instruction on how to provide such patients with information on, or how to refer such patients to, resources in the local community, such as domestic violence centers and other advocacy groups, that provide legal aid, shelter, victim counseling, batterer counseling, or child protection services, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Medical Association Continuing Medical Education or American Osteopathic Association approved Category I-A continuing education

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related to the practice of osteopathic medicine or under osteopathic auspices. Home study courses approved by the above agencies will be acceptable. If the applicant has not already completed the required continuing medical education, upon submission of an affidavit of good cause, the applicant will be allowed six months to complete this requirement.

3. Completion of two hours of continuing medical education relating to prevention of medical errors which includes a study of root cause analysis, error reduction and prevention, and patient safety, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Medical Association Continuing Medical Education or American Osteopathic Association approved Category I-A continuing education related to the practice of osteopathic medicine or under osteopathic auspices. One hour of a two hour course which is provided by a facility licensed pursuant to Chapter 395, F.S., for its employees may be used to partially meet this requirement.

(e) Demonstrate compliance with the financial responsibility pursuant to Section 456.048, F.S., and as outlined in Rule 64B15-7.006, F.A.C., below.

(3) Restrictions. For purposes of carrying out the provisions of Sections 458.3475 and 459.023, F.S., every anesthesiologist assistant is prohibited from being supervised by any physician whose license to practice medicine is on probation.

Specific Authority 459.023, 459.005 FS. Law Implemented 459.023, 456.013(7), 456.031, 456.033 FS. History–New 8-2-05.

64B15-7.004 Requirements for Approval of Training Programs. Anesthesiologist assistant programs approved and recognized by the State of Florida must hold full accreditation or provisional (initial) accreditation from the Committee on Accreditation of Allied Health Education Programs (CAAHEP).


64B15-7.005 Anesthesiologist Assistant Protocols and Performance. (1) Every anesthesiologist or group of anesthesiologists, upon entering into a supervisory relationship with an anesthesiologist

assistant must file with the Board a written protocol, to include, at a minimum, the criteria set forth in Section 459.023(2)(b), F.S. (2) Anesthesiologist assistants may perform duties set forth in Section 459.023(3)(a), F.S., under the direct supervision of an

anesthesiologist and as set forth in the protocol required by subsection (1) above. (3) The supervising anesthesiologist shall delegate only tasks and procedures to the anesthesiologist assistant which are within

the supervising physician’s scope of practice. The anesthesiologist assistant may work in any setting that is within the scope of practice of the supervising anesthesiologist’s practice.

(4) Continuity of supervision in practice settings requires the anesthesiologist assistant to document in the anesthesia record any change in supervisor.

(5) All tasks and procedures performed by the anesthesiologist assistant must be documented in the appropriate medical record.

Specific Authority 459.005, 459.023 FS. Law Implemented 459.015(1)(o), 459.023 FS. History–New 8-2-05.

64B15-7.006 Financial Responsibility. Pursuant to Section 456.048, F.S., all anesthesiologist assistants shall carry malpractice insurance or demonstrate proof of financial responsibility. Any applicant for licensure shall submit proof of compliance with Section 456.048, F.S., or submit proof that the applicant meets the criteria to be granted an exemption to the Board office prior to licensure. All licensees shall submit such proof as a condition of biennial renewal or reactivation. Acceptable proof of financial responsibility shall include:

(1) Professional liability coverage of at least $100,000 per claim with a minimum annual aggregate of at least $300,000 from an authorized insurer under Section 624.09, F.S., a surplus lines insurer under Section 626.914(2), F.S., a joint underwriting association under Section 627.351(4), F.S., a self-insurance plan under Section 627.357, F.S., or a risk retention group under Section 627.942, F.S.; or

(2) An unexpired irrevocable letter of credit as defined by Chapter 675, F.S., which is in the amount of at least $100,000 per claim with a minimum aggregate availability of at least $300,000 and which is payable to the anesthesiologist assistant as beneficiary. Any person claiming exemption from the financial responsibility law pursuant to Section 456.048(2), F.S., must timely document such exemption at initial certification, biennial renewal, and reactivation.


64B15-7.007 Anesthesiologist Assistant Licensure Renewal and Reactivation. (1) An anesthesiologist assistant must renew his licensure on a biennial basis. Upon request by the Board or Department, the

licensee must submit satisfactory documentation of compliance with the requirements set forth below. (2) Requirements for Renewal. (a) Completion of the anesthesiologist assistant licensure renewal application on the appropriate form provided by the

Department. (b) Submission of a signed, sworn statement of no felony convictions in the previous two years. (c) Submission of a written statement attesting to completion of 40 hours of Continuing Medical Education in the previous two

years, or provide documentation of current certification issued by the NCCAA.

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(d) For all licensees no more and no less than one hour shall consist of training in domestic violence which includes information on the number of patients in that professional’s practice who are likely to be victims of domestic violence and the number who are likely to be perpetrators of domestic violence, screening procedures for determining whether a patient has any history of being either a victim or a perpetrator of domestic violence, and instruction on how to provide such patients with information on, or how to refer such patients to, resources in the local community, such as domestic violence centers and other advocacy groups, that provide legal aid, shelter, victim counseling, batterer counseling, or child protection services, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Medical Association Continuing Medical Education or American Osteopathic Association approved Category I-A continuing education related to the practice of osteopathic medicine or under osteopathic auspices. Home study courses approved by the above agencies will be acceptable.

(e) For all licensees one hour of Category I American Medical Association Continuing Medical Education or American Osteopathic Association approved Category I-A continuing education related to the practice of osteopathic medicine or under osteopathic auspices, which includes the topics of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome; the modes of transmission, including transmission from healthcare worker to patient and patient to healthcare worker; infection control procedures, including universal precautions; epidemiology of the disease; related infections including TB; clinical management; prevention; and current Florida law on AIDS and its impact on testing, confidentiality of test results, and treatment of patients. Any hours of said CME may also be counted toward the CME license renewal requirement. In order for a course to count as meeting this requirement, licensees practicing in Florida must clearly demonstrate that the course includes Florida law on HIV/ AIDS and its impact on testing, confidentiality of test results, and treatment of patients. Only Category I hours shall be accepted.

(f) Notwithstanding the provisions of paragraphs (d) and (e), above, an anesthesiologist assistant may complete continuing education on end-of-life care and palliative health care in lieu of continuing education in HIV/AIDS or domestic violence, if that anesthesiologist assistant has completed the HIV/AIDS or domestic violence continuing education in the immediately preceding biennium. This allows for end-of-life care and palliative health care continuing education to substitute for HIV/AIDS or domestic violence continuing education in alternate biennia.

(g) Completion of two hours of continuing medical education relating to prevention of medical errors which includes a study of root cause analysis, error reduction and prevention, and patient safety, and which is approved by any state or federal government agency, or nationally affiliated professional association, or any provider of Category I or II American Medical Association Continuing Medical Education or American Osteopathic Association approved Category I-A continuing education related to the practice of osteopathic medicine or under osteopathic auspices. One hour of a two hour course which is provided by a facility licensed pursuant to Chapter 395, F.S., for its employees may be used to partially meet this requirement.

(3) Reactivation of Inactive License. To reactivate an inactive license, the licensee must: (a) Submit to the Department the original inactive license; (b) Provide the Department with licensure verification from each state in which the licensee is licensed to practice as an

anesthesiologist assistant, or a statement that the licensee is licensed only in Florida; (c) Provide to the Department a statement of medical activities from the date the licensee became inactive to the present; or, if

the licensee has not practiced as an anesthesiologist assistant for at least 2 of the 4 years preceding application for reactivation, the licensee must either:

1. Demonstrate completion of the University of South Florida (USF) Anesthesia Competency Assessment or an equivalent anesthesia assessment program approved by the Board; or

2. Re-take and successfully complete the NCCAA certification examination. (d) Submit to the Department a statement of any criminal or disciplinary actions pending in any jurisdiction; (e) Submit proof of completion of the continuing medical education requirements in compliance with paragraphs

64B15-7.007(2)(c), (d), (e), (f) and (g), F.A.C., for each biennium in which the license was inactive; (f) Submit the protocol as set forth in Rule 64B15-7.005, F.A.C.; (g) Demonstrate financial responsibility as set forth in Rule 64B15-7.006, F.A.C.; and (h) Pay the appropriate fees, as set forth in Rule 64B15-7.012, F.A.C. (4) Licensure Renewal or Reactivation. (a) Application for renewal as a licensed anesthesiologist assistant must be made upon a form supplied by the Department. (b) Renewal application forms submitted to the Board must be complete in every detail and must be typed or legibly printed in

black ink. (c) Application for reactivation shall be made in writing and in accordance with Section 456.036, F.S. (5) The renewal or reactivation fees are found in Rule 64B15-7.012, F.A.C. (6) The failure of any license holder to either renew the license or elect inactive status before the license expires shall cause the

license to become delinquent. (a) The delinquent status licensee must affirmatively apply for active or inactive status during the licensure cycle in which the

license becomes delinquent. The failure by the delinquent status licensee to cause the license to be reactivated or made inactive before the expiration of the licensure cycle in which the license became delinquent shall render the license null and void without further action by the Board or the Department.

(b) The delinquent status licensee who applies for license reactivation or inactive status shall:

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1. File with the Department the completed application for inactive status as required by Section 456.036, F.S., or apply for licensure reactivation as required by Section 456.036, F.S.;

2. Pay to the Board either the license reactivation fee or the inactive status fee, the delinquency fee, and if applicable, the processing fee; and

3. If reactivation is elected, demonstrate compliance with the continuing education requirements found in Rule 64B15-7.007, F.A.C.

Specific Authority 456.013, 456.031(1)(a), 456.033(1), 459.005, 459.023 FS. Law Implemented 456.013, 456.031(1), 456.033, 456.036, 459.023 FS. History–New 6-27-06.

64B15-7.008 Notice of Noncompliance. (1) Pursuant to Section 456.073(3), F.S., the Department is authorized to provide a notice of noncompliance for an initial

offense of a minor violation if the board establishes by rule a list of minor violations. A minor violation is one which does not endanger the public health, safety, and welfare and which does not demonstrate a serious inability to practice the profession. A notice of noncompliance in lieu of other action is authorized only if the violation is not a repeat violation and only if there is only one violation. If there are multiple violations, then the Department may not issue a notice of noncompliance, but must prosecute the violations under the other provisions of Section 456.073, F.S. A notice of noncompliance may be issued to a licensee for a first time violation of one or both of the violations listed in paragraph (3)(b). Failure of a licensee to take action in correcting the violation within 15 days after notice shall result in the institution of regular disciplinary proceedings.

(2) The department shall submit to the board a monthly report detailing the number of notices given, the number of cases completed through receipt of a notarized statement of compliance from the licensee, and the types of violations for which notices of noncompliance have been issued. Notices of noncompliance shall be considered by the probable cause panels when reviewing a licensee’s subsequent violations of a same or similar offense.

(3) The following violations are those for which the board authorizes the Department to issue a notice of noncompliance: (a) Failing to include the specific disclosure statement required by Section 456.062, F.S., in any advertisement for a free,

discounted fee, or reduced fee service, examination or treatment. (b) Violating any of the following provisions of Chapter 459, F.S., as prohibited by Sections 459.023 and 459.015(1)(bb), F.S.: 1. Section 459.023, F.S., which provides for criminal penalties for the practice as an anesthesiologist assistant without an active

license. A notice of noncompliance would be issued for this violation only if the subject of the investigation met the following criteria: the subject was the holder of a license to practice as an anesthesiologist assistant at all time material to the matter; that license was otherwise in good standing; and that license was or will be renewed and placed in an active status within 90 days of the date it reverted to delinquent status based on failure to renew the license. If the license was in a delinquent status for more than 90 days and the individual continued to practice, then the matter would proceed under the other provisions of Sections 456.073 and 456.035(1), F.S.

2. Failing to notify the board of a change of practice location, contrary to Section 456.035(1), F.S.

Specific Authority 456.073(3), 459.023 FS. Law Implemented 456.073(3), 459.023 FS. History–New 8-2-05.

64B15-7.009 Citation Authority. (1) Pursuant to Section 456.077, F.S., the Board sets forth below those violations for which there is no substantial threat to the

public health, safety, and welfare; or, if there is a substantial threat to the public health, safety, and welfare, such potential for harm has been removed prior to the issuance of the citation. Next to each violation is the penalty to be imposed. In addition to any administrative fine imposed, the Respondent may be required by the department to pay the costs of investigation.

(2) If the violation constituted a substantial threat to the public health, safety, and welfare, such potential for harm must have been removed prior to issuance of the citation.

(3) The following violations with accompanying penalty may be disposed of by citation with the specified penalty:

VIOLATIONS PENALTY

(a) CME violations. Within twelve months of the date the citation is issued, (Section 459.023, F.S.); Respondent must submit certified documentation of completion of (Sections 459.015(1)(g), (x), F.S.); all CME requirements for the period for which the citation was (Sections 456.072(1)(e), (s), F.S.) issued; prior to renewing the license for the next biennium,

Respondent must document compliance with the CME requirements for the relevant period; AND pay a $250 fine.

1. Failure to document required HIV/AIDS CME. $250 fine. (Section 456.033, F.S.)

2. Failure to document required domestic violence or $250 fine. end-of-life and palliative health care CME.

(Section 456.031, F.S.)

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3. Failure to document required prevention of medical $250 fine. errors CME.

(Section 456.013(7), F.S.)

4. Failure to document both the required HIV/AIDS and $500 fine. domestic violence, or end-of-life and palliative health care CME.

5. Documentation of some, but not all, 40 hours $25 fine for each hour not documented. of required CME for license renewal.

(b) Obtaining license renewal by negligent $2500 fine. misrepresentation.

(Section 459.023, F.S.); (Section 459.015(1)(a), F.S.)

(c) Failure to document any of the 40 hours of required $2500 fine. CME for license renewal.

(Section 459.023, F.S.); (Section 459.015(1)(x), F.S.)

(d) Practice on an inactive or delinquent license. (Section 456.036(1), F.S.); (Section 459.013(1)(a), F.S.); (Section 459.015(1)(x), F.S.); (Section 459.023, F.S.)

1. For a period of up to nine months. $100 for each month or part thereof.

2. For a period of nine months to twelve months. $150 for each month or part thereof.

(e) Failure to notify Department of change of practice and/ $125 fine. or mailing address.

(Section 456.035, F.S.); (Section 459.015(1)(g), F.S.); (Section 459.018(3), F.S.); (Section 459.023, F.S.)

(f) Failure of the anesthesiologist assistant to clearly $250 fine. identify that he/she is an anesthesiologist assistant.

(Section 459.015(1)(g), F.S.); (Section 459.023, F.S.)

(g) Failure to report to the Department of addition/deletion/ $125 fine. change of supervising physician(s).

(Section 456.035, F.S.); (Section 459.015(1)(g), F.S.); (Section 459.023, F.S.)

(4) Citations shall be issued to licensees by the Bureau of Investigative Services only after review by the legal staff of the Department of Health, Division of Regulation. Such review may be by telephone, in writing, or by facsimile machine.

(5) The procedures described herein apply only for an initial offense of the alleged violation. Subsequent violation(s) of the same rule or statute shall require the procedures of Section 456.073, F.S., to be followed. In addition, should an initial offense for which a citation could be issued occur in conjunction with other violations, then the procedures of Section 456.073, F.S., shall apply.

(6) The subject has 30 days from the date the citation becomes a final order to pay any fine imposed and costs. All fines and costs are to be made payable to the “Department of Health” and sent to the Department of Health in Tallahassee. A copy of the citation shall accompany the payment of the fine.

Specific Authority 456.077, 459.005, 459.023 FS. Law Implemented 456.077, 459.023 FS. History–New 8-2-05.

64B15-7.010 Disciplinary Guidelines. (1) Purpose. Pursuant to Section 456.072, F.S., the Boards provide within this rule disciplinary guidelines which shall be

imposed upon anesthesiologist assistant applicants or licensees whom it regulates under Chapters 458 and 459, F.S. The purpose of this rule is to notify such applicants and licensees of the ranges of penalties which will routinely be imposed unless the Boards find it necessary to deviate from the guidelines for the stated reasons given within this rule. The ranges of penalties provided below are based upon a single count violation of each provision listed; for multiple counts of the violated provisions or a combination of the violations the Boards shall consider a higher penalty than that for a single, isolated violation. Each range includes the lowest and

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highest penalty and all penalties falling between. The purposes of the imposition of discipline are to punish the applicants or licensees for violations and to deter them from future violations; to offer opportunities for rehabilitation, when appropriate; and to deter other applicants or licensees from violations.

(2) Violations and Range of Penalties. In imposing discipline upon anesthesiologist assistant applicants and licensees, in proceedings pursuant to Sections 120.57(1) and (2), F.S., the Board shall act in accordance with the following disciplinary guidelines and shall impose a penalty within the range corresponding to the violations set forth below. The verbal identification of offenses are descriptive only; the full language of each statutory provision cited must be consulted in order to determine the conduct included.

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VIOLATIONS RECOMMENDED PENALTIES

First Offense Subsequent Offenses

(a) Attempting to obtain a license by (a) From suspension of license or (a) From denial of license to revocation

bribery, fraud or through an error of the certificate to revocation, with ability to of license with ability to reapply in not

Department or the Board. reapply, or denial of licensure. less than three years and a fine up to

(Section 456.072(1)(h), F.S.); $5,000.00 to denial of license without

(Section 459.015(1)(a), F.S.) ability to reapply.

(b) Action taken against license by (b) From imposition of discipline (b) From imposition of discipline

another jurisdiction. comparable to the discipline which comparable to the discipline which would

(Section 456.072(1)(f), F.S.); would have been imposed if the have been imposed if the

(Section 459.015(1)(b), F.S.) substantive violation had occurred in substantive violation had occurred in

Florida to reprimand through Florida to suspension and revocation

suspension and/or denial of the license until the license is unencumbered in the

until the license is unencumbered in the jurisdiction in which disciplinary action

jurisdiction in which disciplinary action was originally taken and an

was originally taken and an administrative fine ranging from

administrative fine ranging from $2,500.00 to $5,000.00.

$1,000.00 to $2,500.00

1. Action taken against license by 1. From revocation with leave to 1. From permanent revocation and an

another jurisdiction relating to reapply in three (3) years, and an administrative fine ranging from

healthcare fraud in dollar amounts in administrative fine ranging from $2,500.00 to $5,000.00, or in the case of

excess of $5,000.00. $1,000.00 to $5,000.00, or in the case of application for licensure, denial of

application for licensure, denial of licensure.

licensure.

2. Action taken against license by 2. From an administrative fine ranging 2. From an administrative fine ranging

another jurisdiction relating to from $1,000.00 to $5,000.00, and a from $2,500.00 to $5,000.00, and

healthcare fraud in dollar amounts of reprimand through suspension of the suspension of the license, followed by a

$5,000.00 or less. license, or in the case of application for period of probation to revocation, or in

licensure, denial of licensure. the case of application for licensure,

denial of licensure.

(c) Guilty of crime directly relating to (c) From reprimand to revocation or (c) From probation to revocation or

practice or ability to practice. denial of license, and an administrative denial of the license, and an

(Section 456.072(1)(c), F.S.) fine of $1,000.00 to $5,000.00. administrative fine of $2,500.00 to

(Section 459.015(1)(c), F.S.) $5,000.00.

1. Involving a crime directly related to 1. From revocation with leave to 1. From permanent revocation and an

healthcare fraud in dollar amounts in reapply in three (3) years, and an administrative fine ranging from

excess of $5,000.00. administrative fine ranging from $2,500.00 to $5,000.00, or in the case of

$1,000.00 to $5,000.00, or in the case of application for licensure, denial of


licensure.

2. Involving a crime directly related to 2. From an administrative fine ranging 2. From an administrative fine ranging

healthcare fraud in dollar amounts of from $1,000.00 to $5,000.00, and a from $2,500.00 to $5,000.00, and

$5,000.00 or less. reprimand through suspension of the suspension of the license, followed by a

license, or in case of application for period of probation to revocation, or in

licensure, denial of licensure. case of application for licensure, denial of

licensure.

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(d) False, deceptive, or misleading (d) From a letter of concern to (d) From a letter of concern to reprimand,

advertising. reprimand, or denial of licensure, and or denial of licensure, and an

(Section 459.015(1)(d), F.S.) an administrative fine ranging from administrative fine ranging from

$1,000.00 to $2,500.00. $1,000.00 to $2,500.00.

(e) Failure to report another licensee in (e) From a letter of concern to probation (e) From reprimand to suspension or

violation. and an administrative fine ranging from denial of licensure, and an administrative

(Section 456.072(1)(i), F.S.); $1,000.00 to $2,500.00, or denial of fine from $2,500.00 to $5,000.00.

(Section 459.015(1)(e), F.S.) licensure.

(f) Aiding unlicensed practice. (f) From reprimand to suspension, (f) From probation to revocation or denial

(Section 456.072(1)(j), F.S.); followed by probation, or denial of of licensure, and an administrative fine

(Section 459.015(1)(f), F.S.) licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

ranging from $1,000.00 to $5,000.00.

(g) Failure to perform legal obligation. (g) For any offense not specifically (g) For any offense not specifically listed

(Section 456.072(1)(k), F.S.); listed herein, based upon the severity of herein, based upon the severity of the

(Section 459.015(1)(g), F.S.) the offense and the potential for patient offense and the potential for patient harm,

harm, from a reprimand to revocation or from a reprimand to revocation or denial

denial of licensure and an and an administrative fine from

administrative fine from $1,000.00 to $2,500.00 to $5,000.00.

$5,000.00.

1. Continuing medical education (CME) 1. Document compliance with the CME 1. Document compliance with the CME

violations. requirements for the relevant period; requirements for the relevant period;

(Section 456.033(9), F.S.) AND: AND:

(Section 456.072(1)(e), F.S.);

(Section 456.072(1)(s), F.S.)

a. Failure to document required HIV/ a. An administrative fine ranging from a. An administrative fine ranging from

AIDS, or end of life care, or palliative $250.00 to $500.00. $500.00 to $1,000.00.

health care.

b. Failure to document required b. An administrative fine ranging from b. An administrative fine of $500.00 to

domestic violence CME or substitute $250.00 to $500.00. $1,000.00.

end-of-life care CME, or CME on the

prevention of medical errors.

(h) Filing a false report or failing to file (h) From a letter of concern to (h) From probation to revocation or

a report as required. revocation, or denial of licensure, and denial of licensure, and an administrative

(Section 456.072(1)(l), F.S.); an administrative fine ranging from fine ranging from $2,500.00 to

(Section 459.015(1)(i), F.S.) $1,000.00 to $5,000.00. $5,000.00.

1. Involving healthcare fraud in dollar 1. From revocation with leave to 1. From permanent revocation and an

amounts in excess of $5,000.00. reapply in three (3) years, and an administrative fine ranging from

administrative fine ranging from $2,500.00 to $5,000.00, or in the case of

$1,000.00 to $5,000.00, or in the case of application for licensure, denial of


licensure.

2. Involving healthcare fraud in dollar 2. From an administrative fine ranging 2. From an administrative fine ranging

amounts of $5,000.00 or less. from $1,000.00 to $5,000.00, and a from $2,500.00 to $5,000.00, and

reprimand through suspension of the suspension of the license, followed by a

license, or in case of application for period of probation to revocation, or in

licensure, denial of licensure. case of application for licensure, denial of

licensure.

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(i) Kickbacks or split fee arrangements.

(Section 459.015(1)(j), F.S.)

(j) Sexual Misconduct.

(Section 450.0141, F.S.);

(Section 456.072(1)(u), F.S.);

(Section 459.015(1)(l), F.S.)

(k) Deceptive, untrue, or fraudulent

representations in the practice of

medicine.

(Sections 456.072(1)(a), (m), F.S.);

(Section 459.015(1)(m), F.S.)

1. Deceptive, untrue, or fraudulent


medicine relating to healthcare fraud in

dollar amounts in excess of $5,000.00.

2. Deceptive, untrue, or fraudulent


medicine relating to healthcare fraud in

dollar amounts of $5,000.00 or less.

(l) Improper solicitation of patients.

(Section 459.015(1)(n), F.S.)

(m) Failure to keep legible written

medical records.

(Section 459.015(1)(o), F.S.)

1. Failure to keep legible written

medical records relating to healthcare

fraud in dollar amounts in excess of

$5,000.00.

2. Failure to keep legible written

medical records relating to healthcare

fraud in dollar amounts of $5,000.00 or

less.

(i) A refund of fees paid by or on behalf

of the patient and from a reprimand and

an administrative fine of $1,000.00 to a

reprimand and an administrative fine of

$5,000.00, or denial of licensure.

(j) From probation to revocation, or

denial of licensure, and an

administrative fine ranging from

$1,000.00 to $5,000.00.

(k) From a letter of concern to

revocation, or denial of licensure, and

an administrative fine ranging from

$1,000.00 to $5,000.00.

1. From revocation with leave to

reapply in three (3) years, and an


$1,000.00 to $5,000.00, or in the case of

application for licensure, denial of

licensure.

2. From an administrative fine ranging

from $1,000.00 to $5,000.00, and a

reprimand through suspension of the

license, or in the case of application for

licensure, denial of licensure.

(l) From an administrative fine ranging

from $1,000.00 to $5,000.00, and a

reprimand to probation, or denial of

licensure.

(m) From letter of concern to a

reprimand, or denial of licensure, and

an administrative fine ranging from

$1,000.00 to $5,000.00.

1. From revocation with leave to

reapply in three (3) years, and an




licensure.


from $1,000.00 to $5,000.00, and a

reprimand through suspension of the

license, or in the case of application for

licensure, denial of licensure.

(i) A refund of fees paid by or on behalf

of the patient and from suspension to

revocation or denial of licensure, and an


$2,500.00 to $5,000.00.

(j) From suspension to revocation or

denial of licensure, and an administrative

fine ranging from $2,500.00 to

$5,000.00.

(k) From probation or denial of licensure,

and an administrative fine ranging from

$2,500.00 to $5,000.00 to revocation.

1. From permanent revocation and an




licensure.


from $2,500.00 to $5,000.00, and

suspension of the license, followed by a

period of probation to revocation, or in

the case of application for licensure,


(l) From suspension to revocation or

denial of licensure, and an administrative

fine from $2,500.00 to $5,000.00.

(m) From a reprimand to suspension

followed by probation, and an


$2,500.00 to $5,000.00, or denial of

licensure.

1. From permanent revocation and an




licensure.


from $2,500.00 to $5,000.00, and

suspension of the license, followed by a

period of probation to revocation, or in

the case of application for licensure,


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(n) Exercising influence on patient for (n) Payment of fees paid by or on behalf (n) Payment of fees paid by or on behalf

financial gain. of the patient and from a reprimand to of the patient and from probation to

(Section 456.072(1)(n), F.S.) probation, or denial of licensure, and an revocation, or denial of licensure, and an

(Section 459.015(1)(q), F.S.) administrative fine ranging from administrative fine ranging from

$2,500.00 to $5,000.00. $2,500.00 to $5,000.00.

(o) Performing professional services not (o) From a letter of concern to (o) From a reprimand to revocation, or

authorized by patient. revocation, or denial of licensure, and denial of licensure, and an administrative

(Section 459.015(1)(s), F.S.) an administrative fine ranging from fine ranging from $2,500.00 to

$1,000.00 to $5,000.00. $5,000.00.

(p) Inability to practice medicine with (p) From reprimand to suspension, (p) From probation to revocation, until

skill and safety. which may be stayed to allow a period the licensee is able to demonstrate ability

(Section 456.072(1)(y), F.S.); of probation with supervision, and a to practice with reasonable skill and

(Section 459.015(1)(w), F.S.) demonstration by the licensee of the safety, followed by probation, or denial of

ability to practice with reasonable skill licensure, and an administrative fine from

and safety, or denial of licensure, and an $2,500.00 to $5,000.00.


$1,000.00 to $2,500.00.

(q)1. Malpractice: practicing below (q)1. From a letter of concern to (q)1. From reprimand to revocation or

acceptable standard of care. revocation, or denial of licensure, and denial of licensure, and an administrative

(Section 459.015(1)(x), F.S.) an administrative fine ranging from fine ranging from $2,500.00 to

$1,000.00 to $5,000.00. $5,000.00.

2. Gross Malpractice. 2. From probation to revocation or 2. From suspension followed by

denial of licensure, and an probation to revocation or denial, and an

administrative fine ranging from administrative fine ranging from

$1,000.00 to $2,500.00. $2,500.00 to $5,000.00.

3. Repeated Malpractice. 3. From a reprimand to revocation, or 3. From probation to revocation or denial

denial of licensure, and an of licensure, and an administrative fine

administrative fine ranging from ranging from $2,500.00 to $5,000.00.

$1,000.00 to $5,000.00.

(r) Performing of experimental (r) From a letter of concern to (r) From suspension to revocation or

treatment without informed consent. suspension, or denial of licensure, and denial of licensure, and an administrative

(Section 459.015(1)(y), F.S.) an administrative fine ranging from fine ranging from $2,500.00 to

$1,000.00 to $5,000.00. $5,000.00.

(s) Practicing beyond scope permitted. (s) From a letter of concern to (s) From probation to suspension or

(Section 456.072(1)(o), F.S.;) reprimand and probation, or denial of revocation or denial of licensure, and an

(Section 459.015(1)(z), F.S.) licensure, and an administrative fine administrative fine ranging from

ranging from $1,000.00 to $5,000.00. $2,500.00 to $5,000.00.

(t) Delegation of professional (t) From reprimand to suspension, (t) From probation to revocation or denial

responsibilities to unqualified person. followed by probation, or denial of of licensure, and an administrative fine

(Section 456.072(1)(p), F.S.); licensure, and an administrative fine ranging from $2,500.00 to $5,000.00.

(Section 459.015(1)(aa), F.S.) ranging from $1,000.00 to $5,000.00.

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(u)1. Violation of law, rule, or failure to (u)1. For any offense not specifically (u)1. From probation to revocation or

comply with subpoena. listed herein, based upon the severity of denial of licensure, and an administrative

(Sections 456.072(1)(b), (q), (cc), F.S.); the offense and the potential for patient fine ranging from $2,500.00 to

(Sections 459.015(1)(bb), (pp), F.S.) harm, from a reprimand to revocation, $5,000.00.

or denial of licensure, and an


$1,000.00 to $5,000.00.

2. Violation of an order of the Board. 2. From a letter of concern and an 2. From a reprimand and an

administrative fine of $1,000.00 to a administrative fine of $2,500.00 to a

letter of concern and an administrative reprimand and an administrative fine of

fine of $5,000.00. $5,000.00 and probation.

(v) Conspiring to restrict another from (v) From a letter of concern to a (v) From a reprimand and an

lawfully advertising services. reprimand and an administrative fine administrative fine of $2,500.00 to a

(Section 459.015(1)(cc), F.S.) ranging from $1,000.00 to $2,500.00. reprimand and an administrative fine of

$5,000.00.

(w) Aiding an unlawful abortion. (w) From probation to revocation, or (w) From suspension to revocation or

(Section 459.015(1)(dd), F.S.) denial of licensure, and an denial of licensure, and an administrative

administrative fine ranging from fine ranging from $2,500.00 to

$1,000.00 to $5,000.00. $5,000.00.

(x) Failure to adequately supervise (x) From a reprimand to probation, or (x) From probation to suspension

assisting personnel. denial of licensure, and an followed by probation, or denial of

(Section 459.015(1)(hh), F.S.) administrative fine ranging from licensure, and an administrative fine

$1,000.00 to $2,500.00. ranging from $2,500.00 to $5,000.00.

(y) Improper use of substances for (y) From a reprimand to suspension, or (y) From suspension to revocation or

muscle building or enhancement of denial of licensure, and an denial of licensure, and an administrative

athletic performance. administrative fine ranging from fine ranging from $2,500.00 to

(Section 459.015(1)(ii), F.S.) $1,000.00 to $5,000.00. $5,000.00.

(z) Use of amygdaline (laetrile). (z) From a reprimand to probation, or (z) From suspension to revocation or

(Section 458.331(1)(ff), F.S.) denial of licensure, and an denial of licensure, and an administrative

administrative fine ranging from fine ranging from $2,500.00 to

$1,000.00 to $2,500.00. $5,000.00.

(aa) Misrepresenting or concealing a (aa) From a reprimand to probation, and (aa) From probation to revocation or

material fact. an administrative fine ranging from denial of licensure without the ability to

(Section 459.015(1)(jj), F.S.) $500.00 to $2,500.00, or the denial of reapply, and an administrative fine

licensure with the ability to reapply, ranging from $500.00 to $5,000.00.

upon payment of a $500.00 fine.

(bb) Improperly interfering with an (bb) From a reprimand to probation, or (bb) From probation to revocation or

investigation or a disciplinary denial of licensure, and an denial of licensure without ability to

proceeding. administrative fine ranging from reapply, and an administrative fine

(Section 456.072(1)(r), F.S.); $1,000.00 to $2,500.00. ranging from $2,500.00 to $5,000.00.

(Section 459.015(1)(kk), F.S.)

(cc) Failing to report any licensee who (cc) From a letter of concern to (cc) From probation to revocation or

is in violation of law. probation, or denial of licensure, and an denial of licensure, and an administrative

(Section 456.072(1)(i), F.S.); administrative fine ranging from fine ranging from $2,500.00 to

(Section 459.015(1)(ll), F.S.) $1,000.00 to $2,500.00. $5,000.00.

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(dd) Providing medical opinion without (dd) From a letter of concern to a (dd) From probation to revocation or

reasonable investigation. reprimand, or denial of licensure, and denial of licensure, and an administrative

(Section 459.015(1)(mm), F.S.) an administrative fine ranging from fine from $2,500.00 to $5,000.00.

$1,000.00 to $2,500.00.

(ee) Theft or reproduction of an (ee) Suspension to revocation, or denial (ee) Revocation or denial of licensure

examination. of licensure without an ability to without ability to reapply.

(Section 456.018, F.S.) reapply.

(ff) Using laser device or product (ff) From a letter of concern to a (ff) From probation to revocation and an

without complying with rules adopted reprimand and an administrative fine administrative fine from

pursuant to Section 501.122(2), F.S. ranging from $1,000.00 to $2,500.00. $2,500.00 to $5,000.00.

(Section 456.072(1)(d), F.S.)

(gg) Having been found liable in a civil (gg) From probation to suspension or (gg) From suspension to revocation and

proceeding for filing a false complaint denial of licensure, and an an administrative fine from $2,500.00 to

against another licensee. administrative fine from $1,000.00 to $5,000.00.

(Section 456.072(1)(g), F.S.) $2,500.00.

(hh) Failure to provide patients with (hh) From a letter of concern to (hh) From probation to revocation and an

information regarding their patient probation and an administrative fine administrative fine from $2,500.00 to

rights. ranging from $500.00 to $2,500.00. $5,000.00.

(Section 456.072(1)(t), F.S.);

(Section 459.015(1)(oo), F.S.)

(ii) Using accident information for (ii) From a reprimand to suspension and (ii) From probation to revocation and an

solicitation purposes. an administrative fine ranging from administrative fine from $2,500.00 to

(Section 456.072(1)(x), F.S.) $1,000.00 to $2,500.00. $5,000.00.

(jj) Testing positive on a (jj) From a letter of concern to (jj) From probation to revocation and an

preemployment or employee probation or a denial of licensure and an administrative fine from $2,500.00 to

ordered drug screening. administrative fine ranging from $5,000.00.

(Section 456.072(1)(z), F.S.) $500.00 to $2,500.00.

(kk) Performing health care services on (kk) From a reprimand to suspension (kk) From probation to revocation and an

the wrong patient, wrong site, wrong and an administrative fine ranging from administrative fine from $2,500.00 to

procedure. $1,000.00 to $2,500.00. $5,000.00.

(Section 456.072(1)(aa), F.S.)

(ll) Leaving a foreign body in a patient. (ll) From a letter of concern to (ll) From a reprimand to suspension and

(Section 456.072(1)(bb), F.S.) probation and an administrative fine an administrative fine ranging from

ranging from $1,000.00 to $2,500.00. $1000.00 to $2,500.00.

(mm) Intentionally submitting a (mm) From a reprimand to (mm) From probation to revocation and

personal injury protection claim, probation and an administrative fine an administrative fine from $2,500.00 to

statement, or bill that has been ranging from $1,000.00 to $2,500.00. $5,000.00.

“upcoded,” or claim, statement, or bill

for services not rendered.

(Sections 456.072(1)(dd), (ee), F.S.)

(nn) Failing to report within 30 days (nn) From a reprimand to suspension or (nn) From probation to revocation and an

action taken against one’s license in a denial of licensure and an administrative fine from $2,500.00 to

another jurisdiction. administrative fine ranging from $5,000.00.

(Section 456.072(1)(w), F.S.) $1000.00 to $2,500.00.

(3) Aggravating and Mitigating Circumstances. Based upon consideration of aggravating and mitigating factors present in an individual case, the Board may deviate from the penalties recommended above. The Board shall consider as aggravating or mitigating factors the following:

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(a) Exposure of patients or public to injury or potential injury, physical or otherwise; none, slight, severe, or death; (b) Legal status at the time of the offense; no restraints, or legal constraints; (c) The number of counts or separate offenses established; (d) The number of times the same offense or offenses have previously been committed by the licensee or applicant; (e) The disciplinary history of the applicant or licensee in any jurisdiction and the length of practice; (f) Pecuniary benefit or self-gain inuring to the applicant or licensee; (g) Any other relevant mitigating factors. (4) The anesthesiologist assistant shall be disciplined by the Board when, after due notice and a hearing in accordance with the

provisions of this rule, it shall find: that the anesthesiologist assistant has held himself out or permitted another to represent him as a licensed physician. If any person addresses the anesthesiologist assistant in a medical setting as “Doctor,” the anesthesiologist assistant must immediately inform that person that the anesthesiologist assistant is not a doctor. Upon a finding by the Board of failure to immediately inform the person, the following penalty shall be imposed: a letter of concern, a reprimand, a 60-day suspension and/or a fine up to $2,500.00; and for any subsequent offense, a fine up to $5,000.00 and/or revocation of the certificate.

Specific Authority 456.079, 459.005, 459.015(5), 459.023 FS. Law Implemented 456.072, 456.079, 459.015(5), 459.023 FS. History–New 11-13-05.

64B15-7.011 Mediation. (1) For purposes of Section 456.078, F.S., the Board designates as being appropriate for mediation, violations of the following

provisions: (a) Failing to comply with the requirements of Sections 381.026 and 381.0261, F.S., to provide patients with information about

their patient rights and how to file a patient complaint; (b) Negligently failing to file a report or record required by state or federal law; (2) The above-outlined provisions shall qualify for mediation only when the violation can be remedied by the licensee, there is

no allegation of intentional misconduct, no patient injury, and the allegations do not involve any “adverse incidents” as defined by Section 456.078(2), F.S.

Specific Authority 456.078 FS. Law Implemented 456.078 FS. History–New 11-13-05.

64B15-7.012 Fees Regarding Anesthesiologist Assistants. The following fees are prescribed by the Board:

(1) The application fee for a person applying to be licensed as an anesthesiologist assistant shall be $300. (2) The initial licensure fee for an anesthesiologist assistant shall be $500. (3) The biennial renewal fee for an active or inactive anesthesiologist assistant licensed pursuant to Section 458.3475 or

459.023, F.S., shall be $500. Licenses not renewed at the end of a biennial period shall automatically become delinquent. (4) The reactivation fee for an inactive anesthesiologist assistant licensure pursuant to Section 458.3475 or 459.023, F.S., shall

be $100. Reactivation shall require payment of the $500 renewal fee and the $100 reactivation fee. (5) The duplicate licensure fee shall be $25.00. (6) Any licensed anesthesiologist assistant who fails to renew his/her licensure by the end of the biennium shall pay a

delinquent fee of $100 upon application for either active or inactive status. (7) The unlicensed activity fee for initial licensure and licensure renewal shall be $5.00.

Specific Authority 456.036(5), (7), 458.309, 458.3475, 459.005, 459.023 FS. Law Implemented 456.036(5), (7), 458.3475, 459.023 FS. History– New 8-2-05.

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CHAPTER 64B15-9 PROCEDURE

64B15-9.001 Organization. (Repealed) 64B15-9.002 Rulemaking Procedures. (Repealed) 64B15-9.003 Declaratory Statements. (Repealed) 64B15-9.004 Decisions Determining Substantial Interests. (Repealed) 64B15-9.005 Licensing. (Repealed) 64B15-9.0055 Definitions. 64B15-9.006 Probable Cause Determination. 64B15-9.007 Forms and Instructions. 64B15-9.008 Board Member Compensation. 64B15-9.0085 Unexcused Absences. 64B15-9.009 Qualifications of Investigators. (Repealed) 64B15-9.015 Exemptions. 64B15-9.016 Conducting Meetings, Hearings and Workshops by Communications Media Technology. (Repealed)

64B15-9.0055 Definitions. The term “administrative medicine” as used in this rule chapter, shall be defined as the administration or management of a private or government organization, by a licensed physician, wherein the physician is required to apply and utilize the medical and clinical knowledge, skills, and judgment that are unique to a licensed physician. Administrative medicine shall include, but is not limited to, administering or managing a hospital or other health service, developing health operational policy, planning or purchasing health services or administering or managing a government healthcare benefit program. Administrative medicine does not include diagnosing or treating patients or the prescription of drugs or controlled substances.

Specific Authority 456.036(15), 459.005 FS. Law Implemented 456.036(9), 459.007(5) FS. History–New 12-7-05.

64B15-9.006 Probable Cause Determination. (1) The probable cause panel shall be composed of at least two (2) members and not more than three (3) members. Not more

than one (1) of the panel members shall be a lay member. Two members of the panel may be either a former professional or consumer board member. Any former professional Board member serving shall hold an active license in good standing to practice osteopathic medicine. In any event, the panel must always contain a present board member.

(2) The probable cause panel members shall be selected by the Chair, one (1) of whom shall be selected by the Chair of the Board as the presiding officer of the panel.

(3) The determination as to whether probable cause exists that a violation of the provisions of Chapters 456 and 459, Florida Statutes, and/or the rules promulgated pursuant thereto, has occurred shall be made by a majority vote of the probable cause panel of the Board.

Specific Authority 120.53, 459.005 FS. Law Implemented 456.073(4) FS. History–New 10-23-79, Formerly 21R-9.06, Amended 1-3-93, Formerly 21R-9.006, 61F9-9.006, Amended 10-15-95, Formerly 59W-9.006, Amended 11-27-97.

64B15-9.007 Forms and Instructions. The following constitutes a list of forms and instructions used by the Department and Board in their dealings with the public:

(1) Application for licensure for osteopathic physician with instructions. (2) Application for certification as a physician’s assistant with instructions. (3) Application for physician assistant prescriptive authority.

Specific Authority 120.53, 459.005 FS. Law Implemented 459.022 FS. History–New 10-23-79, Formerly 21R-9.07, 21R-9.007, Amended 11-9-93, Formerly 61F9-9.007, 59W-9.007.

64B15-9.008 Board Member Compensation. For purposes of board member compensation under subsection (4) of Section 455.207, F.S., “other business involving the board” is defined to include:

(1) Board meetings; (2) Any meetings of committees of the board officially appointed by the chair as set out in the official minutes of the board

where statutory authority is given by the practice act; (3) Meetings of a board member with Department staff or contractors of the Department at the Department’s request. Any

participation or meeting of members noticed or unnoticed will be on file in the board office; (4) Where a board member has been requested by the Secretary of the Department to participate in a meeting; (5) Probable cause panel meetings; and

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(6) All participation in board-authorized meetings with professional associations of which the board is a member or invitee. This would include, but not be limited to, all meetings of national associations of which the board is a member as well as board-authorized participation in meetings of national or professional associations or organizations involved in educating, regulating, or reviewing the profession over which the board has statutory authority; and

(7) Conference calls for which licensing or disciplinary action is agendaed or which exceed one hour in duration.

Specific Authority 120.53, 459.005 FS. Law Implemented 456.011 FS. History–New 2-14-82, Amended 4-30-85, Formerly 21R-9.08, 21R-9.008, 61F9-9.008, Amended 10-15-95, Formerly 59W-9.008.

64B15-9.0085 Unexcused Absences. An absence shall be deemed excused if the Board members absence is caused by health problem or condition verified in writing by a physician, or by an accident or similar unforeseeable tragedy or event, and the Board member submits to the Board office a statement in writing attesting to the event and its circumstances prior to the next Board meeting.

Specific Authority 456.011 FS. Law Implemented 456.011 FS. History–New 1-3-93, Formerly 21R-9.0085, 61F9-9.0085, Amended 10-15-95, Formerly 59W-9.0085.

64B15-9.015 Exemptions. Any licensed osteopathic physician who is a spouse of a person on active duty with the Armed Forces of the United States, who is absent from this state because of the spouse’s duties with the Armed Forces, and who, at the time the absence became necessary, was in good standing with the Board of Osteopathic Medicine, shall be exempt from biennial renewal of his or her license, payment of required fees hereunder, and performance of any other act on his or her part necessary for license renewal.

Specific Authority 456.024, 459.005 FS. Law Implemented 456.024 FS. History–New 4-8-90, Formerly 21R-9.015, 61F9-9.015, Amended 10-15-95, 12-28-95, Formerly 59W-9.015.

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CHAPTER 64B15-10 FEES

64B15-10.002 Application, Certification and License Fees.64B15-10.003 Active Status Fees.64B15-10.0031 Inactive Status Renewal Fee.64B15-10.0032 Reactivation Fee.64B15-10.0033 Retired Status Fee.64B15-10.004 Duplicate Certificate Fees.64B15-10.005 Registration Fee for Dispensing Practitioners.64B15-10.0055 Registration Fee for Residents, Interns and Fellows.64B15-10.007 Unlicensed Activity Fee. (Repealed)64B15-10.0075 Unlicensed Activity Fee.64B15-10.008 Change of Status Fee.64B15-10.009 Delinquent Status Fee.64B15-10.010 Fees for Board Approved Continuing Education Providers.

64B15-10.002 Application and Licensure Fees. (1) The application fee for an osteopathic physician license shall be $200. This fee is nonrefundable. (2) The application fee for a limited license shall be $100. This fee is nonrefundable. (3) The initial license fee paid upon submission of the application for licensure as an osteopathic physician shall be $400 if the

application for initial licensure is approved during the first year of the biennium, and $200 if the application for initial licensure is approved during the second year of the biennium.

(4) The application fee for an osteopathic faculty certificate shall be $400.00. (5) Physician assistant fees shall be those set out in Rule 64B15-6.013, F.A.C.

Specific Authority 456.013(2), 456.025(1), 459.0077, 459.0092 FS. Law Implemented 456.013(2), 459.007, 459.0077, 459.0092 FS. History–New 10-23-79, Amended 10-3-83, Formerly 21R-10.02, Amended 5-13-87, 4-21-88, 10-28-91, 11-9-92, 4-1-93, Formerly 21R-10.002, 61F9-10.002, Amended 12-28-95, Formerly 59W-10.002, Amended 12-13-98, 2-26-02.

64B15-10.003 Active Status Renewal Fees. Licenses shall be renewed biennially in accordance with the rules of the Department. Biennial active status renewal fee for osteopathic physicians shall be $400.

Specific Authority 459.005, 459.009(2), (3)(b) FS. Law Implemented 459.008, 459.009(3)(b), 459.022(7)(b) FS. History–New 10-23-79, Amended 10-3-83, 4-8-84, Formerly 21R-10.03, Amended 5-13-87, 4-21-88, 7-19-89, 10-28-91, Formerly 21R-10.003, 61F9-10.003, Amended 2-1-95, Formerly 59W-10.003, Amended 12-13-98, 2-26-02.

64B15-10.0031 Inactive Status Renewal Fee. The renewal fee for inactive status license shall be $200.00 for an osteopathic physician.

Specific Authority 456.036 FS. Law Implemented 456.036 FS. History–New 4-17-95, Formerly 59W-10.0031, Amended 2-26-02.

64B15-10.0032 Reactivation Fee. The fee for reactivating an inactive or retired status license shall be: $200.00 for an osteopathic physician.

Specific Authority 456.036(15), 459.005, 459.009 FS. Law Implemented 456.036, 459.009 FS. History–New 4-17-95, Formerly 59W-10.0032, Amended 12-13-98, 7-19-06.

64B15-10.0033 Retired Status Fee. The fee for a retired status license shall be $50.00 for an osteopathic physician.

Specific Authority 456.036(15), 459.005 FS. Law Implemented 456.036(12) FS. History–New 7-19-06.

64B15-10.004 Duplicate Certificate Fees. (1) The fee for obtaining a duplicate license, certificate, or wall certificate shall be twenty-five ($25.00) dollars. (2) Any person desiring certification of any Board documents from the custodian of records as official public records shall

submit that request along with a certification fee of twenty-five ($25.00) dollars. Duplicating fees as provided in Section 119.07, F.S., shall also apply.

Specific Authority 456.025, 459.055 FS. Law Implemented 456.025 FS. History–New 1-29-86, Amended 10-28-91, Formerly 21R-10.004, 61F9-10.004, 59W-10.004.

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64B15-10.005 Registration Fee for Dispensing Practitioners. Every practitioner who dispenses medicinal drugs for human consumption to his patients in the regular course of practice for fee or remuneration of any kind, whether direct or indirect, must register and pay a fee of $100.00 at the time of registration and upon renewal of his license.

Specific Authority 459.005 FS. Law Implemented 465.0276 FS. History–New 1-10-89, Formerly 21R-10.005, Amended 8-29-93, Formerly 61F9-10.005, Amended 10-15-95, Formerly 59W-10.005.

64B15-10.0055 Registration Fee for Residents, Interns and Fellows. Every resident, intern or fellow registering with the Department pursuant to Rule 64B15-22.004, F.A.C., shall pay a fee of $100 at the time of initial registration.

Specific Authority 459.009, 459.021 FS. Law Implemented 459.021 FS. History–New 12-7-92, Formerly 21R-10.0055, 61F9-10.0055, 59W-10.0055.

64B15-10.0075 Unlicensed Activity Fee. The Department of Health is authorized to collect an additional $5.00 with each initial licensure fee and each biennial renewal fee for the purpose of investigating and prosecuting the unlicensed practice of osteopathic medicine.


64B15-10.008 Change of Status Fee. A licensee shall pay a change of status fee of one hundred dollars ($100) when the licensee applies for a change in licensure status at any time other than during licensure renewal. The renewal period shall begin ninety (90) days prior to the end of the biennium and shall end on the last day of the biennium.

Specific Authority Section 14(8), 94-119, Laws of Florida. Law Implemented 14(8), 94-119, Laws of Florida. History–New 2-1-95, Formerly 59W-10.008, Amended 2-26-02.

64B15-10.009 Delinquent Status Fee. A delinquent status licensee shall pay a delinquency fee of four hundred dollars ($400) when the licensee applies for active or inactive status.

Specific Authority 456.036 FS. Law Implemented 456.036 FS. History–New 2-1-95, Amended 12-28-95, Formerly 59W-10.009, Amended 11-27-97, 2-26-02.

64B15-10.010 Fees for Board Approved Continuing Education Providers. (1) The initial fee for approval as a continuing education provider shall be $250. (2) The biennial renewal fee for an approved continuing education provider shall be $250.

Specific Authority 456.025(7), 459.005 FS. Law Implemented 456.025(7) FS. History–New 2-26-02.

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CHAPTER 64B15-12 EXAMINATIONS AND LICENSURE

64B15-12.001 Examinations. 64B15-12.003 Applications for Licensure. 64B15-12.004 Personal Appearance by Applicant. 64B15-12.005 Limited Licensure. 64B15-12.006 Active Status License. 64B15-12.007 Inactive Status License. 64B15-12.008 Delinquent License. 64B15-12.009 Osteopathic Faculty Certificate.

64B15-12.001 Examinations. (1) Pursuant to Section 455.574(1)(c), F.S., the Board hereby approves and designates the use of an examination prepared by

the National Board of Osteopathic Medical Examiners as the examination prescribed by Section 459.006(3), F.S., for use by the Department.

(2) The minimum passing score on this examination shall be determined by the National Board of Osteopathic Medical Examiners.

(a) In order to pass this examination a candidate must obtain a scaled score of 75 or better on this examination. (b) This scaled score of 75 is statistically equivalent to one and one half (1 1/2) standard deviations below the mean raw score

for the group of persons who have been examined as a part of the national program of examination of osteopathic physician candidates.

(3) For any applicant who has successfully completed Parts I and II of the National Board of Osteopathic Medical Examiners’ examination, who has not taken or has not passed Part III of the National Board of Osteopathic Medical Examiners’ examination in a timely manner, the Board of Osteopathic Medicine determines that successful completion of the COMVEX (Comprehensive Osteopathic Medical Variable-Purpose Examination) is a substantially similar examination to the National Board of Osteopathic Medical Examiners’ examination Part III, and will be accepted by this Board.

Specific Authority 456.017(1)(c), 459.005, 459.006(3) FS. Law Implemented 456.017(1)(c), 459.006(3) FS. History–New 10-23-79, Formerly 21R-12.01, Amended 10-30-91, Formerly 21R-12.001, 61F9-12.001, Amended 10-15-95, Formerly 59W-12.001, Amended 4-28-98.

64B15-12.003 Applications for Licensure. (1) Applications for licensure by examination must include a completed application form and appropriate fee as set forth in

Section 459.0055, F.S., and subsection 64B15-10.001(1), F.A.C. The instructions and application form, DH-MQA 1029, 6/00, effective 9-26-00, entitled “Section II: Application Form Initial Licensure Application” is hereby incorporated by reference, and may be obtained from the Board office. Such application and fee shall expire one year from the date on which the application is initially received by the Board. After a period of one year a new application and fee must be submitted.

(2) Applicants for licensure examination must have their application forms and fees submitted and received by the Board office and all information and documentation complete at least 30 days before the scheduled Board meeting in order to be considered by the Board. Applicants making initial application for licensure shall complete educational courses approved by the Board pursuant to Rule 64B15-13.001, F.A.C., on human immunodeficiency virus and acquired immune deficiency syndrome, domestic violence, and prevention of medical errors. Any applicant who has not completed any such courses at the time of licensure shall, upon an affidavit showing good cause, be allowed 6 months to complete this requirement.

(3) Applications for licensure by endorsement must include a completed application form and appropriate fee as set forth in Section 459.0055, F.S., and subsection 64B15-10.002(1), F.A.C. The application form, shall be the same form as referenced in subsection (1) above. Such application and fee shall expire one year from the date on which the application is initially received by the Board. After a period of one year, a new application and fee must be submitted.

Specific Authority 456.031(4), 456.033(7), 459.005, 459.0055(1)(i) FS. Law Implemented 456.031(2), 456.033(6), 459.0055, 459.006, 459.007 FS. History–New 6-4-91, Formerly 21R-12.003, 61F9-12.003, Amended 10-15-95, Formerly 59W-12.003, Amended 9-26-00, 3-9-03.

64B15-12.004 Personal Appearance by Applicant. (1) The Board may require a personal appearance of any applicant for licensure or certification as a condition of said licensure

or certification. The Board will provide adequate notice as to the time and place of the appearance as well as a statement of the purpose and reasons for said appearance.

(2) In determining whether an appearance is required for malpractice actions under this section, the following will be considered:

(a) The number of malpractice actions or claims, and their disposition. (b) The status of the physician at the time of the claim as a resident or intern. (c) The number of years elapsing since the last malpractice claim. (d) Any additional relevant factors.

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Specific Authority 459.005, 459.0055 FS. Law Implemented 459.0055 FS. History–New 12-22-91, Formerly 21R-12.004, 61F9-12.004, Amended 10-15-95, Formerly 59W-12.004.

64B15-12.005 Limited Licensure. (1) Each applicant for limited licensure pursuant to Section 459.0075, F.S., shall file an application and submit an affidavit to

the Board. For purposes of this rule, retired means previously separated or withdrawn from the practice of Osteopathic Medicine, as distinguished from a relocation of the applicant’s practice to a different geographic area.

(2) Any applicant for limited licensure who has been out of active practice of Osteopathic Medicine for more than 3 years prior to application for limited license must, as a condition of said licensure, function under the supervision of the full-time director of a local health unit for at least six months consistent with the following criteria:

(a) The applicant shall prepare a practice plan, detailing the practice setting, other facilities, and numbers and types of patients expected.

(b) The supervising physician must be easily available and must have a pre-arranged plan of activity or treatment for specific patient problems which the supervised limited licensee may carry out in the absence of any complications.

(c) It shall be the responsibility of the limited licensee to insure that the director of the local health unit files with the Board a statement certifying that the limited licensee has completed the training program.

(d) The Board shall, for good cause, reduce the supervision period. (3) It shall be the responsibility of the full-time county public health director to assist in the supervision of any limited licensee.

In the absence of specific approval by the Board of supervision by another physician other than the director, the director shall be responsible for said supervisor. This supervision shall be consistent with the following criteria:

(a) The supervising physician shall be easily available to the limited licensee. (b) The supervising physician shall report to the Board any information or actions by the limited licensee which would be

grounds for revocation of a limited license. (c) The supervising physician shall respond to any written request from the Board for comments or information regarding the

limited licensee’s performance. (4) Any person desiring to obtain a limited license pursuant to Section 459.0075, F.S., shall complete or shall have completed

40 hours of continuing education in the two year period preceding licensure.

Specific Authority 459.005, 459.0075 FS. Law Implemented 459.0075 FS. History–New 10-28-93, Formerly 61F9-12.005, Amended 10-15-95, Formerly 59W-12.005, Amended 11-27-97.

64B15-12.006 Active Status License. (1) The Department shall renew an active license to practice osteopathic medicine upon timely receipt of the complete

application for active status, the biennial renewal fee, and certification that the licensee has demonstrated participation in the continuing medical education required by Rule 64B15-13.001, F.A.C.

(2) The “complete application” for purposes of active status or inactive status licensure shall be the renewal card. Any licensee whose license has been inactive for more than two consecutive biennial renewal periods shall complete the initial licensure application for election of either active or inactive status.

Specific Authority Sect. 14, 94-119, Laws of Florida. Law Implemented Sect. 14, 94-119, Laws of Florida. History–New 11-28-94, Formerly 59W-12.006.

64B15-12.007 Inactive Status License. (1) Any licensee may elect at the time of license renewal to place the license into inactive status by filing with the Board a

complete application for inactive status as defined in Rule 64B15-12.006, F.A.C., and paying the inactive status fee. (2) An inactive status licensee may change to active status at any time provided the licensee meets the continuing education

requirements of Rule 64B15-13.001, F.A.C. Inactive status licensees choosing active status at the time of renewal must pay the active status renewal fee and the reactivation fee. Inactive status licensees choosing active status at any other time than at the time of license renewal shall pay the difference between the inactive status renewal fee and the active status renewal fee, the reactivation fee and the fee to change licensure status. However, a licensee whose license has been in inactive status for more than two consecutive biennial licensure cycles and who has not been practicing medicine on a full-time basis in another jurisdiction during such period of time, shall be required to appear before the Board before the license can be placed into active status. The Board at the time of the appearance shall impose upon the licensee reasonable conditions necessary to insure that the licensee can practice with the care and skill sufficient to protect the health, safety and welfare to the public. For purposes of this rule, “full-time basis” shall be defined as working as a physician for over 20 hours per week.

Specific Authority 456.036 FS. Law Implemented 456.036 FS. History–New 11-28-94, Amended 3-28-95, Formerly 59W-12.007, Amended 12-30-01, 11-2-05.

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64B15-12.008 Delinquent License. (1) The failure of any license holder to elect active or inactive status before the license expires shall cause the license to

become delinquent. (2) The delinquent status licensee must affirmatively apply for active or inactive status during the licensure cycle in which the

license becomes delinquent. The failure by the delinquent status licensee to cause the license to become active or inactive before the expiration of the licensure cycle in which the license became delinquent shall render the license null and void without further action by the Board or the Department.

(3) The delinquent status licensee who applies for active or inactive license status shall: (a) File with the Board the complete application for either active or inactive status as defined in Rule 64B15-12.006, F.A.C.; (b) Pay to the Board either the active status or inactive status renewal fee, the delinquency fee, and if applicable the change of

status fee; and (c) If active status is elected, demonstrate compliance with the continuing education requirements found in Rule

64B15-13.001, F.A.C.

Specific Authority 456.036 FS. Law Implemented 456.036 FS. History–New 11-28-94, Formerly 59W-12.008, Amended 2-26-02

64B15-12.009 Osteopathic Faculty Certificate. (1) An Osteopathic Faculty Certificate may be issued by the Department to a faculty member of a school accredited by the

American Osteopathic Association upon the request of the dean of the school if the faculty member has demonstrated to the Board that:

(a) The faculty member is currently licensed to practice osteopathic medicine in another jurisdiction of the United States; and (b) Is a graduate of a school of osteopathic medicine accredited by the American Osteopathic Association; and (c) Files an application and otherwise meets the requirements contained in Section 459.0055, F.S.; and (d) Has submitted the application fee required by subsection 64B15-10.002(6), F.A.C. (2) An Osteopathic Faculty Certificate authorizes the holder to practice only in conjunction with his or her teaching duties at an

accredited school of osteopathic medicine or in its affiliated teaching hospitals or clinics. (3) Faculty Certificates shall automatically expire upon termination of the holder’s relationship with the school or after a

period of 24 months, whichever occurs first. Faculty Certificates are subject to cancellation or revocation by the Board for failure to comply with Chapters 456 and 459, F.S., and Chapter 64B15, F.A.C.


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CHAPTER 64B15-13 CONTINUING EDUCATION

64B15-13.001 Continuing Education for Biennial Renewal. 64B15-13.002 Continuing Education Requirements for Reactivation. 64B15-13.003 Proof of Completion of Continuing Medical Education Hours. 64B15-13.004 Application for Board Approved Provider Status. 64B15-13.0045 Standards for Board Approved Providers. 64B15-13.005 Performance of Pro Bono Medical Services.

64B15-13.001 Continuing Education for Biennial Renewal. (1)(a) Every person licensed pursuant to Chapter 459, F.S., except those licensed as physician assistants pursuant to Section

459.022, F.S., shall be required to complete forty (40) hours of continuing medical education courses approved by the Board in the twenty-four (24) months preceding each biennial renewal period as established by the Department. Seven of the continuing medical education hours required for renewal shall be one hour HIV/AIDS course, one hour Domestic Violence, one hour Risk Management Course, one hour Florida Laws and Rules, one hour on the laws regarding the use and abuses of controlled substances, and two hours Prevention of Medical Errors Course. The completion of the seven required continuing medical education hours set forth above shall be obtained as set forth in paragraph (3)(b) of this rule.

(b) A licensee shall not be required to complete continuing medical education if the initial license is issued subsequent to July 1 of the second year of the biennium, except as found in paragraph 64B15-13.001(1)(a), F.A.C.

(2) At least twenty (20) of the forty (40) hours of the continuing medical education required under this rule shall be American Osteopathic Association approved Category I-A continuing education related to the practice of osteopathic medicine or under osteopathic auspices.

(3)(a) For purposes of this rule, risk management means the identification, investigation, analysis, and evaluation of risks and the selection of the most advantageous method of correcting, reducing, or eliminating identifiable risks and domestic violence as defined in Section 741.30, F.S.

(b) The continuing medical education found in paragraph 64B15-13.001(1)(a), F.A.C., with regard to Risk Management, Florida Laws and Rules, controlled substances and the prevention of medical errors shall be obtained by the completion of live, participatory attendance courses. However, the continuing medical education found in paragraph 64B15-13.001(1)(a), F.A.C., with regard to HIV/AIDS, domestic violence, or the alternative end-of-life/palliative care as set forth in subsection (7) of this rule may be obtained by the completion of non-live/participatory attendance.

(c) For purposes of this rule, Florida laws and rules means Chapters 456 and 459, F.S., and Rule Chapter 64B15, F.A.C. (d) The one hour of Risk Management may be fulfilled by attending at least three (3) hours of disciplinary matters at a regular

meeting of the Board of Osteopathic Medicine in compliance with the following: 1. The licensee must sign in with the Executive Director of the Board, or designee, before the meeting day begins. 2. The licensee must remain in continuous attendance. 3. The licensee must sign out with the Executive Director of the Board, or designee, at the end of the meeting day or at such

other earlier time as affirmatively authorized by the Board. The licensee may receive CME credit in risk management for attending the disciplinary portion of a Board meeting only if the licensee is attending on that day solely for that purpose; the licensee may not receive such credit if appearing at the Board meeting for another purpose. Members of the Board of Osteopathic Medicine may receive risk management credit for such attendance at one full day of disciplinary hearings at a regular meeting of the Board.

4. A licensee may use no more than five (5) hours of continuing education in the area of risk management for the purpose of completing the continuing education requirements for each biennial renewal.

(e) For purposes of this rule, a two hour Prevention of Medical Errors course shall include a study of root cause analysis, error reduction and prevention, and patient safety. The course shall address medication errors, surgical errors, diagnostic inaccuracies, and system failures, and shall provide recommendations for creating safety systems in health care organizations. The course must include information relating to the five most mis-diagnosed conditions during the previous biennium, as determined by the Board. The following areas have been determined as the five most mis-diagnosed conditions: wrong-site/patient surgery; cancer; cardiac; timely diagnosis of surgical complications and failing to diagnose pre-existing conditions prior to prescribing contraindicated medications.

(4) The following courses are approved by the Board: (a) Organized courses of post graduate study offered by or approved by the American Osteopathic Association or the American

Medical Association or any of their divisional societies; (b) Organized courses of post graduate study sponsored by a medical school recognized and approved by the American

Osteopathic Association or the American Medical Association; (c) Organized courses of post graduate study sponsored by a specialty college of the American Osteopathic Association or the

American Medical Association; (d) Organized courses of post graduate study sponsored by the Public Health Service, state or territorial health services, or a

branch of the United States Armed Services;

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(e) Fellowships approved by the American Osteopathic Association or the American Medical Association; Internship or residency approved by the American Osteopathic Association or the Accreditation Council for Graduate Medical Education; each fellow, intern and/or resident shall be responsible for obtaining the continuing medical education required under this rule. For fellows, interns, and/or residents in approved AOA, AMA or ACGME educational training programs, ten (10) continuing medical education credit hours shall be awarded for successful completion of each 6 month training program period;

(f) Teacher hours, lecture hours or scientific papers read and published which are approved for credit by the American Osteopathic Association;

(g) Annual convention and mid-year seminars sponsored by the Florida Osteopathic Medical Association; (h) Internship or residency approved by the American Osteopathic Association or the Accreditation Council for Graduate

Medical Education; (i) Routine hospital programs, including clinical and pathological conferences, mortality review, medical audit committees,

tumor board, peer review or utilization review; that are approved by the American Osteopathic Association, (AOA), the American Medical Association, (AMA), or by the Board.

(5) Home study hours up to a maximum of eight (8) hours per biennium may be utilized toward continuing education requirements for renewal. In order to be acceptable, said home study hours must be approved by the AOA, the AMA, the Board, or approved for credit as a college or university extension course with approved grading and evaluation standards.

(6) In addition to the continuing medical education credits authorized above, a volunteer expert witness who is providing expert witness opinions for cases being reviewed pursuant to Chapter 459, F.S., shall receive 5.0 hours of credit in the area of risk management for each case reviewed. Former Board members serving on the Probable Cause Panel shall be allowed a maximum of 15 hours of credit per biennium pursuant to Section 456.013. F.S. A volunteer expert may not accrue in excess of 15 hours of credit per biennium pursuant to this paragraph.

(7) In lieu of the domestic violence course or the HIV/AIDS course, a licensee may complete a course in end of life care and palliative health care if the licensee has completed an approved domestic violence course in the immediately preceding biennium.

(8) All applicants for an initial license, reactivation or reinstatement of their license who obtained the required domestic violence, end of life and palliative health care, or HIV/AIDS course for initial licensure, reactivation or reinstatement within six (6) months immediately preceding licensure renewal may use the same domestic violence, end of life palliative health care, or HIV/AIDS hours obtained for initial licensure, reactivation or reinstatement to meet the requirements for licensure renewal.

Specific Authority 459.005, 459.008(4) FS. Law Implemented 456.013(5), (6), (7), 459.008, 459.008(4) FS. History–New 10-23-79, Amended 1-29-86, Formerly 21R-13.01, Amended 12-5-89, 4-8-91, 2-16-92, Formerly 21R-13.001, Amended 1-10-94, Formerly 61F9-13.001, Amended 10-25-95, Formerly 59W-13.001, Amended 1-19-98, 6-3-98, 4-14-99, 5-26-02, 5-10-04, 7-27-04, 2-9-05, 2-14-06.

64B15-13.002 Continuing Education Requirements for Reactivation. (1) Every license holder pursuant to Chapter 459, F.S., whose license has been inactive for more than one (1) year shall be

required to complete continuing education requirements as a condition for reactivating his license. (2) The continuing education requirements shall be twenty (20) attendance hours for each year the license was inactive. At

least seven of the continuing medical education hours required for renewal shall be as found in paragraph 64B15-13.001(1)(a), F.A.C.

(3) The courses listed in Rule 64B15-13.001, F.A.C., shall constitute the list of approved courses under this rule.

Specific Authority 459.009(1) FS. Law Implemented 459.009(1) FS. History–New 10-23-79, Amended 4-17-85, Formerly 21R-13.02, Amended 5-13-87, Formerly 21R-13.002, Amended 1-10-94, Formerly 61F9-13.002, Amended 8-27-95, Formerly 59W-13.002, Amended 12-9-97, 2-9-05.

64B15-13.003 Proof of Completion of Continuing Medical Education Hours. (1) At the time of licensure renewal, each physician shall be required to submit to the Department the renewal application, fee,

and an affirmation that the physician has earned the required 40 hours of continuing medical education (C.M.E.) pursuant to paragraph 64B15-13.001(1)(a), F.A.C. Each physician shall be responsible for maintaining proof of C.M.E. hours for the biennium in which the hours were earned for renewal and for a period of at least four (4) years after the close of the renewal period for which the physician is submitting the hours.

(2) The Board will conduct an audit of randomly selected licensees to assure compliance with C.M.E. requirements. Failure to maintain documentation or the submission of false or misleading information or documentation shall subject the licensee to disciplinary action.

Specific Authority 459.005 FS. Law Implemented 459.008(6) FS. History–New 1-29-86, Amended 4-8-91, Formerly 21R-13.003, Amended 1-10-94, Formerly 61F9-13.003, 59W-13.003.

64B15-13.004 Application for Board Approved Provider Status. (1) Entities or individuals who wish to become approved providers of continuing education must submit the approval fee set

forth in subsection 64B15-10.010(1), F.A.C., and an application which contains the following information, and which is accompanied by the following documentation:

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(a) The name of the contact person who will fulfill the reporting and documentation requirements for approved providers and who will assure the provider’s compliance with Rule 64B15-13.0045, F.A.C.; and

(b) The qualifications of all instructors, which may be evidenced by a curriculum vitae or professional licensure in the subject area taught.

(2) If granted, provider approval will be granted for a period not to exceed the time from the date of approval to the end of the next successive licensure biennium after approval was obtained. Application for renewal of provider status shall be made at least 90 days prior to the end of the biennium in which approval expires and must be accompanied by the biennial renewal fee set forth in subsection 64B15-10.010(2), F.A.C. Renewal applications shall contain all information required for initial provider approval as well as course outlines and information evidencing compliance with Rule 64B15-13.0045, F.A.C., for each course offered during the provider status.

Specific Authority 456.027, 459.0055 FS. Law Implemented 456.025, 456.027, 459.0055 FS. History–New 8-12-02.

64B15-13.0045 Standards for Board Approved Providers. Approved continuing professional education providers and providers authorized pursuant to Rule 64B15-13.004, F.A.C., shall comply with the following requirements:

(1) All courses shall reflect appropriate didactic and clinical training for the subject matter and shall be designed to meet specifically stated educational objectives.

(2) Instructors shall be adequately qualified by training, experience or licensure to teach specified courses. (3) Facilities and equipment for each course in which patients are treated during instruction shall be adequate for the subject

matter and method of instruction. (4) Course length shall be sufficient to provide meaningful education in the subject matter presented. One half hour or one hour

of continuing education credit shall be awarded for each 25 or 50 minutes of actual classroom or clinical instruction, respectively. No continuing education credit shall be awarded for participation of less than 25 minutes.

(5) Providers shall provide written certification to each participant who completes a continuing education course or portion of that course which consists of at least 25 minutes of instruction. Certification shall include the participant’s name and license number, the provider’s name and number, the course title, instructor, location, date offered and hours of continuing education credit awarded, and validation through the signature of the provider, official representative or instructor.

(6) Providers shall maintain records of each course offering for 4 years following each licensure biennium during which the course was offered. Course records shall include a course outline which reflects its educational objectives, the instructor’s name, the date and location of the course, participants’ evaluations of the course, the hours of continuing education credit awarded for each participant and a roster of participants by name and license number.

(7) Providers’ records and courses shall be subject to Board review. Failure to maintain the standards set forth in this rule shall subject the provider to the suspension or rescission of the providership.

(8) Providers shall comply with rules promulgated by the Department of Health concerning the electronic transmission of course attendance information necessary to implement the electronic tracking system.

Specific Authority 456.027, 459.0055 FS. Law Implemented 456.025, 456.027, 459.0055 FS. History–New 8-12-02.

64B15-13.005 Performance of Pro Bono Medical Services. (1) Up to 10 hours, per biennium, of continuing education credit may be fulfilled by the performance of pro bono medical

services to the indigent or to underserved populations or in areas of critical need within the state where the licensee practices. The standard for determining indigency shall be low-income (no greater than 150% of the federal poverty level) or uninsured persons. Credit shall be given on an hour per hour basis.

(2) The Board approves for credit under this rule, the following entities: (a) The Department of Health; (b) Community and Migrant Health Centers funded under section 330 of the United States Public Health Service Act; and (c) Volunteer Health Care provider programs contracted to provide uncompensated care under the provisions of Section

766.1115, F.S., with the Department of Health. (3) For services provided to an entity not specified under this rule a licensee must apply for prior approval in order to receive

credit. In the application for approval, licensees shall disclose the type, nature and extent of services to be rendered, the facility where the services will be rendered, the number of patients expected to be served, and a statement indicating that the patients to be served are indigent. If the licensee intends to provide services in underserved or critical need areas, the application shall provide a brief explanation as to those facts.

(4) Unless otherwise provided through Board order, no licensee who is subject to a disciplinary action that requires additional continuing education as a penalty, shall be permitted to use pro bono medical services as a method of meeting the additional continuing education requirements.

Specific Authority 456.013(7), 459.005 FS. Law Implemented 456.013(7) FS. History–New 12-7-92, Formerly 21R-13.005, 61F9-13.005, Amended 10-25-95, Formerly 59W-13.005, Amended 10-19-03.

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CHAPTER 64B15-14 PRACTICE REQUIREMENTS

64B15-14.001 Advertisings.64B15-14.0015 Notice to the Department of Mailing Address and Place of Practice of Licensee.64B15-14.002 Notice of Withdrawal From Patient Care. (Repealed) 64B15-14.003 HIV/AIDS: Knowledge of Antibody Status; Action to be Taken. 64B15-14.004 Standards for the Prescription of Obesity Drugs. 64B15-14.005 Standards for the Use of Controlled Substances for Treatment of Pain. 64B15-14.006 Standards of Practice for Surgery. 64B15-14.007 Standard of Care for Office Surgery. 64B15-14.0075 Osteopathic Physician Office Incident Reporting.64B15-14.0076 Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation.64B15-14.0077 Approval of Osteopathic Physician Office Accrediting Organizations.64B15-14.008 Standards for Telemedicine Practice.64B15-14.009 Standards for Office Based Opioid Addiction Treatment.64B15-14.010 Physician Practice Standard Regarding Do Not Resuscitate (DNR) Orders.

64B15-14.001 Advertisings. (1) The Board permits the dissemination to the public of legitimate information in accordance with the Board’s rules, regarding

the practice of osteopathic medicine and where and from whom osteopathic medical services may be obtained, so long as such information is in no way false, deceptive, or misleading.

(2) No physician shall disseminate or cause the dissemination of any advertisement or advertising which is in any way false, deceptive, or misleading. Any advertisement or advertising shall be deemed by the Board to be false, deceptive, or misleading if it:

(a) Contains a misrepresentation of facts; or (b) Makes only a partial disclosure of relevant facts; or (c) Creates false or unjustified expectations of beneficial assistance; or (d) Appeals primarily to a layperson’s fears, ignorance, or anxieties regarding his state of well-being; or (e) Contains any representation or claims as to which the osteopathic physician referred to in the advertising does not expect to

perform; or (f) Contains any representation, statement, or claim which misleads or deceives; or (g) States or implies that the osteopathic physician is a specialist in any aspect of the practice of osteopathic medicine unless he

has in fact completed post-doctoral training in the recognized specialty field including internship, residency, fellowship, or alternate training requirements, accredited by either the AOA or the ACGME for the number of years contemplated for completion of the specialty program. However, a physician may indicate the services offered and may state that the practice is limited to one or more types of services when this is, in fact, the case; or

(h) States or implies that an osteopathic physician has been certified as a specialist in any aspect of the practice of osteopathic medicine unless he or she has in fact received such certification, meets the training requirements of paragraph 64B15-14.001(2)(g), F.A.C., includes the name of the certifying agency in any statement or advertisement claiming certification, and the certifying agency meets the following criteria:

1. The organization has been granted Section 501(c) status under the Internal Revenue Code. 2. The organization shall have full time administrative staff, housed in dedicated office space which is appropriate for the

organization’s program. 3. The organization shall have bylaws, a code of ethics to guide the practice of its members, and an internal review and control

process, including budgetary practices, to ensure effective utilization of resources. 4. The organization shall be national in scope, one of whose central purposes is credentialing of Physicians. An umbrella

organization composed of more than one academy and board shall also have formal procedures for recognition and discipline of academies and boards.

5. With regards to certification, the organization shall be able to demonstrate the existence of appropriate procedures to ensure, with regard to any examination given after the effective date of this rule, that:

a. Such examination is of sufficient breadth and scope as to cover the specialty field; b. The exams and answers thereto are adequately secured; c. A standard grading system with pass/fail standards has been established in advance of testing; d. The proctoring of all examinations shall be done by independent proctors, i.e., at a minimum, members of the certification

board not related to, in practice or association with, or having a financial interest in the applicant being tested; e. The grant or denial of certification is based on objective performance, skill, knowledge, and merit of the candidate; 6. The organization has an interest in the continuing proficiency of its members, by requiring periodic recertification and/or

documentation of continuing medical education hours as well as continued practice in the field of certification.

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(i) Represents that professional services can or will be competently performed for a stated fee when this is not the case, or makes representations with respect to fees for professional services that do not disclose all variables affecting the fees that will, in fact, be charged; or

(j) Conveys the impression that the osteopathic physician disseminating the advertising or referred to therein possesses qualifications, skills or other attributes, which are superior to other osteopathic physicians, other than a simple listing of earned professional, post-doctoral or other professional achievements recognized by the Board; or

(k) Fails to conspicuously identify the osteopathic physician by name in the advertisement or fails to conspicuously identify the osteopathic physician referred to in the advertising as an osteopathic physician.

(3) As used in the rules of this Board, the terms “advertisement” and “advertising” shall mean any statements, oral or written, disseminated to or before the public or any portion thereof, with the intent of furthering the purpose, either directly or indirectly, of selling professional services, or offering to perform professional services, or inducing members of the public to enter into any obligation relating to such professional services.

(4) It shall be the responsibility of any duly licensed osteopathic physician who utilizes the electronic media for the purpose of advertising to insure that an exact copy of the audio tape and/or video tape is maintained and preserved for a period of at least 90 days from the date that the actual advertisement is aired or shown through the electronic media.

Specific Authority 459.005, 459.015(1)(d), (e), (l), (m), (o), (v) FS. Law Implemented 459.015(1)(d), (e), (l), (m), (o), (v) FS. History–New 7-1-80, Formerly 21R-14.01, Amended 10-28-91, Formerly 21R-14.001, 61F9-14.001, 59W-14.001.

64B15-14.0015 Notice to the Department of Mailing Address and Place of Practice of Licensee. Each licensee shall provide by mail written notification to the department of the licensee’s current mailing address and place of practice. The term “place of practice” means the primary physical location where the osteopathic physician practices the profession of osteopathic medicine.


64B15-14.003 HIV/AIDS: Knowledge of Antibody Status; Action to be Taken. The Board of Osteopathic Medicine strongly encourages all licensees under its jurisdiction who are involved in invasive procedures to undergo testing to determine their HIV status. A licensee who tests positive for HIV antibodies is encouraged to enter and comply with the requirements of the Physician Recovery Network.

Specific Authority 456.032, 459.005 FS. Law Implemented 456.032, 459.015(1)(w) FS. History–New 3-29-94, Formerly 61F9-14.003, 59W-14.003.

64B15-14.004 Standards for the Prescription of Obesity Drugs. The prescription of medication for the purpose of enhancing weight loss should only be performed by osteopathic physicians with training and experience to treat obesity. All licensees are expected to abide by the following guidelines and standards in the utilization of any drug or synthetic compound for the purpose of providing medically assisted weight loss.

(1) To justify the use of weight loss enhancers as set forth above, the patient must have a Body Mass Index (BMI) of 30 or above, or a BMI of greater than 25 with at least one comorbidity factor, or a measurable body fat content equal to or greater than 25% of total body weight for male patients or 30% of total body weight for women. The prescription of such weight loss enhancers is not generally appropriate for children. Any time such prescriptions are made for children, the prescribing osteopathic physician must obtain a written informed consent from the parent or legal guardian of the minor patient in addition to complying with the other guidelines and standards set forth in this rule. BMI is calculated by use of the formula BMI = kg/m2. The osteopathic physician may deviate from these guidelines in individual cases where two or more comorbidity factors are present.

(2) An initial evaluation of the patient shall be conducted prior to the prescribing, ordering, dispensing or administering of any drug or synthetic compound and such evaluation shall include an appropriate physical and complete history; appropriate tests related to medical treatment for weight loss; and appropriate medical referrals as indicated by the physical, history and testing; all in accordance with general medical standards of care.

(a) The initial evaluation may be delegated to an appropriately educated and trained osteopathic physician assistant licensed pursuant to Chapter 459, F.S., or an appropriately educated and trained advanced registered nurse practitioner licensed pursuant to Chapter 464, F.S.

(b) If the initial evaluation required above is delegated to an osteopathic physician assistant or to an advanced registered nurse practitioner, then the delegating osteopathic physician must personally review the resulting medical records prior to the issuance of an initial prescription, order or dosage.

(3) Prescriptions or orders for any drug or synthetic compound for the purpose of assisting in weight loss must be in writing and signed by the prescribing osteopathic physician. Initial prescriptions or orders of this type shall not be called into a pharmacy by the osteopathic physician or by an agent of the osteopathic physician.

(4) At the time of delivering the initial prescription or providing the initial supply of such drugs to a patient, the prescribing osteopathic physician must personally meet with the patient and personally obtain an appropriate written informed consent from the patient. Such consent must state that there is a lack of scientific data regarding the potential danger of long term use of combination

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weight loss treatments, and shall discuss potential benefits versus potential risks of weight loss treatments. The written consent must also clearly state the need for dietary intervention and physical exercise as a part of any weight loss regimen. A copy of the signed informed consent shall be included in the patient’s permanent medical record.

(5) Each osteopathic physician who is prescribing, ordering or providing weight loss enhancers to patients must assure that such patients undergo an in-person re-evaluation within 2 to 4 weeks of receiving a prescription, order or dosage. The re-evaluation shall include the elements of the initial evaluation and an assessment of the medical effects of the treatment being provided. Any patient that continues on a drug or synthetic compound assisted weight loss program shall be re-evaluated at least once every 3 months.

(6) Each osteopathic physician who prescribes, orders, dispenses or administers any drug or synthetic compound for the purpose of assisting a patient in weight loss shall maintain medical records in compliance with Rule 64B15-15.004, F.A.C., and must also reflect compliance with all requirements of this rule.

(7) Each osteopathic physician who prescribes, orders, dispenses or administers weight loss enhancers for the purpose of providing medically assisted weight loss shall provide to each patient a legible copy of the Weight-Loss Consumer Bill of Rights as set forth in Sections 501.0575(1)(a) through (e)3., F.S.

(8) Any osteopathic physician who advertises practice relating to weight loss or whose services are advertised by another person or entity shall be responsible for assuring that such advertising meets the requirements of Rule 64B15-14.001, F.A.C. In addition, advertising of weight loss treatment shall be considered false, deceptive or misleading if it contains representations that:

(a) Promise specific results; (b) Raise unreasonable expectations; (c) Claim rapid, dramatic, incredible, or safe weight loss; (d) State or suggest that diets or exercise are not required; or (e) Suggest that weight loss is effortless or magical.

Specific Authority 459.005, 459.0135 FS. Law Implemented 459.0135 FS. History–New 3-29-98, Amended 9-18-02.

64B15-14.005 Standards for the Use of Controlled Substances for Treatment of Pain. (1) Pain management principles. (a) The Board of Osteopathic Medicine recognizes that principles of quality medical practice dictate that the people of the State

of Florida have access to appropriate and effective pain relief. The appropriate application of up-to-date knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The Board encourages osteopathic physicians to view effective pain management as a part of quality medical practice for all patients with pain, acute or chronic, and it is especially important for patients who experience pain as a result of terminal illness. All osteopathic physicians should become knowledgeable about effective methods of pain treatment as well as statutory requirements for prescribing controlled substances.

(b) Inadequate pain control may result from an osteopathic physician’s lack of knowledge about pain management or an inadequate understanding of addiction. Fears of investigation or sanction by federal, state, and local regulatory agencies may also result in inappropriate or inadequate treatment of chronic pain patients. Osteopathic physicians should not fear disciplinary action from the Board or other state regulatory or enforcement agencies for prescribing, dispensing, or administering controlled substances including opioid analgesics, for a legitimate medical purpose and that is supported by appropriate documentation establishing a valid medical need and treatment plan. Accordingly, these guidelines have been developed to clarify the Board’s position on pain control, specifically as related to the use of controlled substances, to alleviate physician uncertainty and to encourage better pain management.

(c) The Board recognizes that controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Osteopathic physicians are referred to the U.S. Agency for Health Care Policy and Research Clinical Practice Guidelines for a sound approach to the management of acute and cancer-related pain. The medical management of pain including intractable pain should be based on current knowledge and research and includes the use of both pharmacologic and non-pharmacologic modalities. Pain should be assessed and treated promptly, and the quantity and frequency of doses should be adjusted according to the intensity and duration of the pain. Osteopathic physicians should recognize that tolerance and physical dependence are normal consequences of sustained use of opioid analgesics and are not synonymous with addiction.

(d) The Board of Osteopathic Medicine is obligated under the laws of the State of Florida to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioid analgesics, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Osteopathic physicians should be diligent in preventing the diversion of drugs for illegitimate purposes.

(e) The Board will consider prescribing, ordering, administering, or dispensing controlled substances for pain to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of pain or if based on sound clinical grounds. All such prescribing must be based on clear documentation of unrelieved pain and in compliance with applicable state or federal law.

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(f) Each case of prescribing for pain will be evaluated on an individual basis. The Board will not take disciplinary action against an osteopathic physician for failing to adhere strictly to the provisions of these guidelines, if good cause is shown for such deviation. The osteopathic physician’s conduct will be evaluated to a great extent by the treatment outcome, taking into account whether the drug used is medically and/or pharmacologically recognized to be appropriate for the diagnosis, the patient’s individual needs including any improvement in functioning, and recognizing that some types of pain cannot be completely relieved.

(g) The Board will judge the validity of prescribing based on the osteopathic physician’s treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient’s pain for its duration while effectively addressing other aspects of the patient’s functioning, including physical, psychological, social, and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.

(2) Definitions. (a) Acute Pain. For the purpose of this rule, “acute pain” is defined as the normal, predicted physiological response to an

adverse chemical, thermal, or mechanical stimulus and is associated with surgery, trauma, and acute illness. It is generally time-limited and is responsive to opioid therapy, among other therapies.

(b) Addiction. For the purpose of this rule, “addiction” is defined as a neurobehavioral syndrome with genetic and environmental influences that results in psychological dependence on the use of substances for their psychic effects and is characterized by compulsive use despite harm. Addiction may also be referred to by terms such as “drug dependence” and “psychological dependence.” Physical dependence and tolerance are normal physiological consequences of extended opioid therapy for pain and should not be considered addiction.

(c) Analgesic Tolerance. For the purpose of this rule, “analgesic tolerance” is defined as the need to increase the dose of opioid to achieve the same level of analgesia. Analgesic tolerance may or may not be evident during opioid treatment and does not equate with addiction.

(d) Chronic Pain. For the purpose of this rule, “chronic pain” is defined as a pain state which is persistent. (e) Pain. For the purpose of this rule, “pain” is defined as an unpleasant sensory and emotional experience associated with

actual or potential tissue damage or described in terms of such damage. (f) Physical Dependence. For the purpose of this rule, “physical dependence” on a controlled substance is defined as a

physiologic state of neuro-adaptation which is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.

(g) Pseudoaddiction. For the purpose of this rule, “pseudoaddiction” is defined as a pattern of drug-seeking behavior of pain patients who are receiving inadequate pain management that can be mistaken for addiction.

(h) Substance Abuse. For the purpose of this rule, “substance abuse” is defined as the use of any substances for non-therapeutic purposes or use of medication for purposes other than those for which it is prescribed.

(i) Tolerance. For the purpose of this rule, “tolerance” is defined as a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a reduced effect is observed with a constant dose.

(3) Guidelines. The Board has adopted the following guidelines when evaluating the use of controlled substances for pain control:

(a) Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

(b) Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the osteopathic physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

(c) Informed Consent and Agreement for Treatment. The osteopathic physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one osteopathic physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the osteopathic physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to:

1. Urine/serum medication levels screening when requested; 2. Number and frequency of all prescription refills; and 3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement). (d) Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the osteopathic physician

should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the osteopathic physician’s evaluation of progress toward stated treatment objectives such as improvement in patient’s pain intensity and improved physical and/or psychosocial function, i.e., ability to work, need of health

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care resources, activities of daily living, and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the osteopathic physician should reevaluate the appropriateness of continued treatment. The osteopathic physician should monitor patient compliance in medication usage and related treatment plans.

(e) Consultation. The osteopathic physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder may require extra care, monitoring, documentation, and consultation with or referral to an expert in the management of such patients.

(f) Medical Records. The osteopathic physician is required to keep accurate and complete records to include, but not be limited to:

1. The medical history and physical examination; 2. Diagnostic, therapeutic, and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed); 8. Instructions and agreements; and 9. Periodic reviews.

Records must remain current and be maintained in an accessible manner and readily available for review. (g) Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled

substances, the osteopathic physician must be licensed in the state and comply with applicable federal and state regulations. Osteopathic physicians are referred to the Physicians Manual: An Informational Outline of the Controlled Substances Act of 1970, published by the U.S. Drug Enforcement Agency, for specific rules governing controlled substances as well as applicable state regulations.

Specific Authority 459.005(1) FS. Law Implemented 459.003(3), 459.015(1)(g), (x) FS. History–New 3-9-00.

64B15-14.006 Standards of Practice for Surgery. The Board of Osteopathic Medicine interprets the standard of care requirement of Section 459.015(1)(x), F.S., and the delegation of duties restrictions of Section 459.015(1)(aa), F.S., with regard to surgery as follows:

(1) The ultimate responsibility for diagnosing medical and surgical problems is that of the licensed allopathic or osteopathic physician who is to perform the surgery. In addition, it is the responsibility of the operating surgeon or an equivalently trained allopathic or osteopathic 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 operating surgeon obtain or witness the signature of the patient on the written form evidencing informed consent.

(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, and endoscopic procedure. 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.

(b) Except in life-threatening emergencies requiring immediate resuscitative measures, once the patient has been prepared for the elective surgery/procedure and the surgical team has been gathered in the operating room and immediately prior to the initiation of any surgical procedure, the surgical team will pause and the operating physician 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 notes of the procedure shall specifically reflect when this confirmation procedure was completed and which personnel on the surgical 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.

(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 allopathic or

osteopathic physician 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 allopathic or osteopathic physician or a physician practicing within a Board approved postgraduate training program.

(5) The rule shall have no application to anesthesia-related activities performed in accordance with Florida law.

Specific Authority 459.005, 459.015(1)(z) FS. Law Implemented 459.015(1)(x), (z), (aa) FS. History–New 10-16-01, Amended 4-5-05.

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64B15-14.007 Standard of Care for Office Surgery. NOTHING IN THIS RULE RELIEVES THE SURGEON OF THE RESPONSIBILITY FOR MAKING THE MEDICAL DETERMINATION THAT THE OFFICE IS AN APPROPRIATE FORUM FOR THE PARTICULAR PROCEDURE(S) TO BE PERFORMED ON THE PARTICULAR PATIENT.

(1) Definitions. (a) Surgery. For the purpose of this rule, surgery is defined as any operative procedure, including the use of lasers, performed

upon the body of a living human being for the purposes of preserving health, diagnosing or curing disease, repairing injury, correcting deformity or defects, prolonging life, relieving suffering or any elective procedure for aesthetic, reconstructive or cosmetic purposes, to include, but not be limited to: incision or curettage of tissue or an organ; suture or other repair of tissue or organ, including a closed as well as an open reduction of a fracture; extraction of tissue including premature extraction of the products of conception from the uterus; insertion of natural or artificial implants; or an endoscopic procedure with use of local or general anesthetic.

(b) Surgeon. For the purpose of this rule, surgeon is defined as a licensed osteopathic physician performing any procedure included within the definition of surgery.

(c) Equipment. For the purpose of this rule, implicit within the use of the term of equipment is the requirement that the specific item named must meet current performance standards.

(d) Office surgery. For the purpose of this rule office surgery is defined as surgery which is performed outside a hospital, an ambulatory surgical center, abortion clinic, or other medical facility licensed by the Department of Health, the Agency for Health Care Administration, or a successor agency. Office surgical procedures shall not be of a type that generally result in blood loss of more than ten percent of estimated blood volume in a patient with a normal hemoglobin; require major or prolonged intracranial, intrathoracic, abdominal, or major joint replacement procedures, except for laparoscopic procedures; directly involve major blood vessels; or are generally emergent or life threatening in nature.

(2) General Requirements for Office Surgery. (a) The surgeon must examine the patient immediately before the surgery to evaluate the risk of anesthesia and of the surgical

procedure to be performed. The surgeon must maintain complete records of each surgical procedure, as set forth in Rule 64B15-15.004, F.A.C., including anesthesia records, when applicable and the records shall contain written informed consent from the patient reflecting the patient’s knowledge of identified risks, consent to the procedure, type of anesthesia and anesthesia provider, and that a choice of anesthesia provider exists, i.e., anesthesiologist, another appropriately trained physician as provided in this rule, certified registered nurse anesthetist, or physician assistant qualified as set forth in subparagraph 64B15-6.010(2)(b)6., F.A.C.

(b) The requirement set forth in paragraph (2)(a) above for written informed consent is not necessary for minor Level I procedures limited to the skin and mucosa.

(c) The surgeon must maintain a log of all Level II and Level III surgical procedures performed, which must include a confidential patient identifier, the type of procedure, the type of anesthesia used, the duration of the procedure, the type of post-operative care, and any adverse incidents, as identified in Section 459.026, F.S. The log and all surgical records shall be provided to investigators of the Department of Health upon request.

(d) In any liposuction procedure, the surgeon is responsible for determining the appropriate amount of supernatant fat to be removed from a particular patient. A maximum of 4000 cc supernatant fat may be removed by liposuction in the office setting. A maximum of 50mg/kg of Lidocaine can be injected for tumescent liposuction in the office setting.

(e) Liposuction may be performed in combination with another separate surgical procedure during a single Level II or Level III operation, only in the following circumstances:

1. When combined with abdominoplasty, liposuction may not exceed 1000 cc of supernatant fat; 2. When liposuction is associated and directly related to another procedure, the liposuction may not exceed 1000cc of

supernatant fat; 3. Major liposuction in excess of 1000 cc supernatant fat may not be performed in a remote location from any other procedure. (f) For elective cosmetic and plastic surgery procedures performed in a physician’s office, the maximum planned duration of

all surgical procedures combined must not exceed 8 hours. Except for elective cosmetic and plastic surgery, the surgeon shall not keep patients past midnight in a physician’s office. For elective cosmetic and plastic surgical procedures, the patient must be discharged within 24 hours of presenting to the office for surgery; an overnight stay is permitted in the office provided the total time the patient is at the office does not exceed 23 hours and 59 minutes including the surgery time. An overnight stay in a physician’s office for elective cosmetic and plastic surgery shall be strictly limited to the physician’ s office. If the patient has not recovered sufficiently to be safely discharged within the timeframes set forth, the patient must be transferred to a hospital for continued post-operative care.

(g) The Board of Osteopathic Medicine adopts the “Standards of the American Society of Anesthesiologists for Basic Anesthetic Monitoring,” approved by House Delegates on October 21, 1986, and last amended on October 21, 1998, as the standards for anesthetic monitoring by any qualified anesthesia provider.

1. These standards apply to general anesthetics, regional anesthetics, and monitored anesthesia care (Level II and III as defined by this rule) although, in emergency circumstances, appropriate life support measures take precedence. These standards may be exceeded at any time based on the judgment of the responsible supervising physician or anesthesiologist. They are intended to

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encourage quality patient care, but observing them cannot guarantee any specific patient outcome. They are subject to revision from time to time, as warranted by the evolution of technology and practice. This set of standards addresses only the issue of basic anesthesia monitoring, which is one component of anesthesia care.

2. In certain rare or unusual circumstances some of these methods of monitoring may be clinically impractical, and appropriate use of the described monitoring methods may fail to detect untoward clinical developments. Brief interruptions of continual monitoring may be unavoidable. For purpose of this rule, “continual” is defined as “repeated regularly and frequently in steady rapid succession” whereas “continuous” means “prolonged without any interruption at any time.”

3. Under extenuating circumstances, the responsible supervising osteopathic physician or anesthesiologist may waive the requirements marked with an asterisk (*); it is recommended that when this is done, it should be so stated (including the reasons) in a note in the patient’s medical record. These standards are not intended for the application to the care of the obstetrical patient in labor or in the conduct of pain management.

a. Standard I. I. Qualified anesthesia personnel shall be present in the room throughout the conduct of all general anesthetics, regional

anesthetics and monitored anesthesia care. II. OBJECTIVE. Because of the rapid changes in patient status during anesthesia, qualified anesthesia personnel shall be

continuously present to monitor the patient and provide anesthesia care. In the event there is a direct known hazard, e.g., radiation, to the anesthesia personnel which might require intermittent remote observation of the patient, some provision for monitoring the patient must be made. In the event that an emergency requires the temporary absence of the person primarily responsible for the anesthetic, the best judgment of the supervising physician or anesthesiologist will be exercised in comparing the emergency with the anesthetized patient’s condition and in the selection of the person left responsible for the anesthetic during the temporary absence.

b. Standard II. I. During all anesthetics, the patient’s oxygenation, ventilation, circulation and temperature shall be continually evaluated. II. OXYGENATION. (A) OBJECTIVE – To ensure adequate oxygen concentration in the inspired gas and the blood during all anesthetics. (B) METHODS: (I) Inspired gas: During every administration of general anesthesia using an anesthesia machine, the concentration of oxygen in

the patient breathing system shall be measured by an oxygen analyzer with a low oxygen concentration limit alarm in use.* (II) Blood oxygenation: During all anesthetics, a quantitative method of assessing oxygenation such as a pulse oximetry shall

be employed.* Adequate illumination and exposure of the patient are necessary to assess color.* III. VENTILATION. (A) OBJECTIVE – To ensure adequate ventilation of the patient during all anesthetics. (B) METHODS: (I) Every patient receiving general anesthesia shall have the adequacy of ventilation continually evaluated. Qualitative clinical

signs such as chest excursion, observation of the reservoir breathing bag and auscultation of breath sounds are useful. Continual monitoring for the presence of expired carbon dioxide shall be performed unless invalidated by the nature of the patient, procedure or equipment. Quantitative monitoring of the volume of expired gas is strongly encouraged.*

(II) When an endotracheal tube or laryngeal mask is inserted, its correct positioning must be verified by clinical assessment and by identification of carbon dioxide analysis, in use from the time of endotracheal tube/laryngeal mask placement, until extubation/ removal or initiating transfer to a postoperative care location, shall be performed using a quantitative method such as capnography, capnometry or mass spectroscopy.*

(III) When ventilation is controlled by a mechanical ventilator, there shall be in continuous use a device that is capable of detecting disconnection of components of the breathing system. The device must give an audible signal when its alarm threshold is exceeded.

(IV) During regional anesthesia and monitored anesthesia care, the adequacy of ventilation shall be evaluated, at least, by continual observation of qualitative clinical signs.

IV. CIRCULATION. (A) OBJECTIVE – To ensure the adequacy of the patient’s circulatory function during all anesthetics. (B) METHODS: (I) Every patient receiving anesthesia shall have the electrocardiogram continuously displayed from the beginning of

anesthesia until preparing to leave the anesthetizing location.* (II) Every patient receiving anesthesia shall have arterial blood pressure and heart rate determined and evaluated at least every

five minutes.* (III) Every patient receiving general anesthesia shall have, in addition to the above, circulatory function continually evaluated

by at least one of the following: palpation of a pulse, auscultation of heart sounds, monitoring of a tracing of intra-arterial pressure, ultrasound peripheral pulse monitoring, or pulse plethysmography or oximetry.

V. BODY TEMPERATURE. (A) OBJECTIVE – To aid in the maintenance of appropriate body temperature during all anesthetics.

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(B) METHODS: Every patient receiving anesthesia shall have temperature monitored when clinically significant changes in body temperature are intended, anticipated or suspected.

(h) The surgeon must assure that the post-operative care arrangements made for the patient are adequate to the procedure being performed as set forth in Rule 64B15-14.006, F.A.C. Management of post-surgical care is the responsibility of the operating surgeon and may be delegated only as set forth in subsection 64B15-14.006(3), F.A.C. If there is an overnight stay at the office in relation to any surgical procedure:

1. The office must provide at least two (2) monitors, one of these monitors must be certified in Advanced Cardiac Life Support (ACLS), and maintain a monitor to patient ratio of at least 1 monitor to 2 patients. Once the surgeon has signed a timed and dated discharge order, the office may provide only one monitor to monitor the patient. The monitor must be certified in Advanced Cardiac Life Support. The full and current crash cart required below must be present in the office and immediately accessible for the monitors.

2. The surgeon must be reachable by telephone and readily available to return to the office if needed. For purposes of this subsection, “readily available” means capable of returning to the office within 15 minutes of receiving a call.

(i) A policy and procedure manual must be maintained in the office, updated annually, and implemented. The policy and procedure manual must contain the following: duties and responsibilities of all personnel, quality assessment and improvement systems comparable to those required by Rule 59A-5.019, F.A.C.; cleaning, sterilization, and infection control, and emergency procedures. This applies only to physician offices at which Level II and Level III procedures are performed.

(j) The surgeon shall establish a risk management program that includes the following components: 1. The identification, investigation, and analysis of the frequency and causes of adverse incidents to patients, 2. The identification of trends or patterns of incidents, 3. The development of appropriate measures to correct, reduce, minimize, or eliminate the risk of adverse incidents to patients,

and 4. The documentation of these functions and periodic review no less than quarterly of such information by the surgeon. (k) The surgeon shall report to the Department of Health any adverse incidents that occur within the office surgical setting.

This report shall be made within 15 days after the occurrence of an incident as required by Section 497.026, F.S. (l) A sign must be prominently posted in the office which states that the office is a doctor’s office regulated pursuant to the

rules of the Board of Osteopathic Medicine as set forth in Rule Chapter 64B15, F.A.C. This notice must also appear prominently within the required patient informed consent.

(3) Level I Office Surgery. (a) Scope. Level I office surgery includes the following: 1. Minor 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.

2. Liposuction involving the removal of less than 4000cc supernatant fat is permitted. 3. Incision and drainage of superficial abscesses, limited endoscopies such as proctoscopies, skin biopsies, arthrocentesis,

thoracentesis, paracentesis, dilation of urethra, cysto-scopic procedures, and closed reduction of simple fractures or small joint dislocations (i.e., finger and toe joints).

4. Pre-operative medications not required or used other than minimal pre-operative tranquilization of the patient; anesthesia is local, topical, or none. No drug-induced alteration of consciousness other than minimal pre-operative tranquilization of the patient is permitted in Level I Office Surgery.

5. Chances of complication requiring hospitalization are remote. (b) Standards for Level I Office Surgery. 1. Training Required. Surgeon’s continuing medical education should include: proper dosages; management of toxicity or

hypersensitivity to regional anesthetic drugs. Basic Life Support Certification is recommended but not required. 2. Equipment and Supplies Required. Oxygen, positive pressure ventilation device, Epinephrine (or other vasopressor),

Corticoids, Antihistamine and Atropine if any anesthesia is used. 3. Assistance of Other Personnel Required. No other assistance is required, unless the specific surgical procedure being

performed requires an assistant. (4) Level II Office Surgery. (a) Scope. 1. Level II Office Surgery is that in which peri-operative medication and sedation are used intravenously, intramuscularly, or

rectally, thus making intra and post-operative monitoring necessary. Such procedures shall include, but not be limited to: hemorrhoidectomy, hernia repair, reduction of simple fractures, large joint dislocations, breast biopsies, colonoscopy, and liposuction involving the removal of up to 4000cc supernatant fat.

2. Level II Office Surgery includes any surgery in which the patient is placed in a state which allows the patient to tolerate unpleasant procedures while maintaining adequate cardiorespiratory function and the ability to respond purposefully to verbal command and/or tactile stimulation. Patients whose only response is reflex withdrawal from a painful stimulus are sedated to a greater degree than encompassed by this definition.

(b) Standards for Level II Office Surgery.

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1. Transfer Agreement Required. The physician must have a transfer agreement with a licensed hospital within reasonable proximity if the physician does not have staff privileges to perform the same procedure as that being performed in the out-patient setting at a licensed hospital within reasonable proximity. “Reasonable proximity” is defined as not to exceed thirty (30) minutes transport time to the hospital.

2. Training Required. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board eligibility by a Board approved by the American Osteopathic Association, the American Board of Medical Specialties, the Accreditation Council on Graduate Medical Education or any other board approved by the Board of Osteopathic Medicine or must be able to establish comparable background, training, and experience. The surgeon and one assistant must be currently certified in Basic Life Support and the surgeon or at least one assistant must be currently certified in Advanced Cardiac Life Support or have a qualified anesthesia provider practicing within the scope of the provider’s license manage the anesthesia.

3. Equipment and Supplies Required. a. Full and current crash cart at the location the anesthetizing is being carried out. The crash cart must include, at a minimum,

the following resuscitative medications: I. Adenosine 6 mg/2 ml x 3 II. Albuterol Inhaler III. Amiodarone 150 mg x 2 IV. Atropine 0.4 mg/ml; 3 ml V. Calcium chloride 10%; 10 ml VI. Dextrose 50%; 50 ml VII. Diphenhydramine 50 mg VIII. Dopamine 200 mg minimum IX. Epinephrine 1:10,000 dilution; 10 ml X. Epinephrine 1:1000 dilution; 1 ml x 3 XI. Flumazenil 0.1 mg/ml; 5 ml x 2 XII. Furosemide 40 mg XIII. Hydrocortisone or Methylprednisolone or Dexamethasone XIV. Lidocaine 100 mg XV. Magnesium sulfate 1 gm x 2 XVI. Narcan (naloxone) 0.4 mg/ml; 3 ml XVII. Propranolol 1 mg x 1 XVIII. Sodium bicarbonate 50 mEq/50 ml XIX. Succinylcholine 1 vial XX. Vasopressin 20 units x 2 XXI. Verapamil 5 mg x 2 b. A Benzodiazepine must be stocked, but not on the crash cart. c. Suction devices, endotracheal tubes, laryngoscopes, etc. d. Positive pressure ventilation device (e.g., Ambu) plus oxygen supply. e. Double tourniquet for the Bier block procedure. f. Monitors for blood pressure/EKG/Oxygen saturation. g. Emergency intubation equipment. h. Adequate operating room lighting. i. Emergency power source able to produce adequate power to run required equipment for a minimum of two (2) hours. j. Appropriate sterilization equipment. k. IV solution and IV equipment. 4. Assistance of Other Personnel Required. The surgeon must be assisted by a qualified anesthesia provider as follows: An

Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician Assistant qualified as set forth in subparagraph 64B15-6.010(2)(b)6., F.A.C., or a registered nurse may be utilized to assist with the anesthesia, if the surgeon is ACLS certified. An assisting anesthesia provider cannot function in any other capacity during the procedure. If additional assistance is required by the specific procedure or patient circumstances, such assistance must be provided by a physician, osteopathic physician, registered nurse, licensed practical nurse, or operating room technician. A physician licensed under Chapter 458 or 459, F.S., a licensed physician assistant, a licensed registered nurse with post-anesthesia care unit experience or the equivalent, credentialed in Advanced Cardiac Life Support or, in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia.

(5) Level IIA Office Surgery. (a) Scope. Level IIA office surgeries are those Level II office surgeries with a maximum planned duration of 5 minutes or less

and in which chances of complications requiring hospitalization are remote. (b) Standards for Level IIA Office Surgery.

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1. The standards set forth in subsection 64B15-14.006(4), F.A.C., must be met except for the requirements set forth in subparagraph 64B15-14.006(4)(b)4., F.A.C., regarding assistance of other personnel.

2. Assistance of Other Personnel Required. During the procedure, the surgeon must be assisted by a physician or physician assistant who is licensed pursuant to Chapter 458 or 459, F.S., or by a licensed registered nurse or a licensed practical nurse. Additional assistance may be required by specific procedure or patient circumstances. Following the procedure, a physician or physician assistant who is licensed pursuant to Chapter 458 or 459, F.S., or a licensed registered nurse must be available to monitor the patient in the recovery room until the patient is recovered from anesthesia. The monitor must be certified in Advanced Cardiac Life Support, or, in the case of pediatric patients, Pediatric Advanced Life Support.

(6) Level III Office Surgery. (a) Scope. 1. Level III Office Surgery is that surgery which involves, or reasonably should require, the use of a general anesthesia or

major conduction anesthesia and pre-operative sedation. This includes the use of: a. Intravenous sedation beyond that defined for Level II office surgery; b. General Anesthesia: loss of consciousness and loss of vital reflexes with probable requirement of external support of

pulmonary or cardiac functions; or c. Major Conduction anesthesia. 2. Only patients classified under the American Society of Anesthesiologist’s (ASA) risk classification criteria as Class I or II

are appropriate candidates for Level III office surgery. a. All Level III surgeries on patient classified as ASA III and higher are to be performed only in a hospital or ambulatory

surgery center. b. For all ASA II patients above the age of 40, the surgeon must obtain, at a minimum, an EKG and a complete workup

performed prior to the performance of Level III surgery in a physician office setting. If the patient is deemed to be a complicated medical patient, the patient must be referred to an appropriate consultant for an independent medical clearance. This requirement may be waived after evaluation by the patient’s anesthesiologist.

(b) Standards for Level III Office Surgery. In addition to the standards for Level II Office Surgery, the surgeon must comply with the following:

1. Training Required. a. The surgeon must have staff privileges at a licensed hospital to perform the same procedure in that hospital as that being

performed in the office setting or must be able to document satisfactory completion of training such as Board certification or Board qualification by a Board approved by the American Osteopathic Association, the American Board of Medical Specialties, the Accreditation Council on Graduate Medical Education or any other board approved by the Board of Osteopathic Medicine or must be able to demonstrate to the accrediting organization or to the Department comparable background, training and experience. In addition, the surgeon must have knowledge of the principles of general anesthesia. If the anesthesia provider is not an anesthesiologist, there must be a licensed M.D., or D.O., anesthesiologist, other than the surgeon, to provide direct supervision of the administration and maintenance of the anesthesia.

b. The surgeon and one assistant must be currently certified in Basic Life Support and the surgeon or at least one assistant must be currently certified in Advanced Cardiac Life Support.

2. Emergency procedures related to serious anesthesia complications should be formulated, periodically reviewed, practiced, updated, and posted in a conspicuous location.

3. Equipment and Supplies Required. a. Equipment, medication, including at least 36 ampules of dantrolene on site, and monitored post-anesthesia recovery must be

available in the office. b. The office, in terms of general preparation, equipment, and supplies, must be comparable to a free standing ambulatory

surgical center, including, but not limited to, recovery capability, and must have provisions for proper recordkeeping. c. Blood pressure monitoring equipment; EKG; end tidal CO2 monitor; pulse oximeter, precordial or esophageal stethoscope,

emergency intubation equipment and a temperature monitoring device. d. Table capable of trendelenburg and other positions necessary to facilitate the surgical procedure. e. IV solutions and IV equipment. 4. Assistance of Other Personnel Required. An Anesthesiologist, Certified Registered Nurse Anesthetist, or Physician

Assistant qualified as set forth in subparagraph 64B15-6.010(2)(c)6., F.A.C., must administer the general or regional anesthesia and an M.D., D.O., Registered Nurse, Licensed Practical Nurse, Physician Assistant, or Operating Room Technician must assist with the surgery. The anesthesia provider cannot function in any other capacity during the procedure. A physician licensed under Chapter 458 or 459 F.S., a licensed physician assistant, or a licensed registered nurse with post-anesthesia care unit experience or the equivalent, and credentialed in Advanced Cardiac Life Support, or in the case of pediatric patients, Pediatric Advanced Life Support, must be available to monitor the patient in the recovery room until the patient has recovered from anesthesia.

Specific Authority 459.005(1), 459.015(1)(z), 459.026 FS. Law Implemented 459.015(1)(g), (x), (z), (aa), 459.026 FS. History–New 11-29-01, Amended 2-23-03, 11-2-05.

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64B15-14.0075 Osteopathic Physician Office Incident Reporting. (1) Definitions. (a) “Adverse incident” for purposes of reporting to the department, is defined in Section 459.026, F.S., as an event over which

the osteopathic physician or other licensee could exercise control and which is associated in whole or in part with a medical intervention, rather than the condition for which such intervention occurred, and which results in the following patient injuries;

1. The death of a patient. 2. Brain or spinal damage to a patient. 3. The performance of a surgical procedure on the wrong patient. 4. The performance of a wrong-site surgical procedure; the performance of a wrong surgical procedure; or the surgical repair of

damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process and if one of the listed procedures in this paragraph results in: death; brain or spinal damage; permanent disfigurement not to include the incision scar; fracture or dislocation of bones or joints; a limitation of neurological, physical or sensory function; or any condition that required transfer of the patient.

5. A procedure to remove unplanned foreign objects remaining from a surgical procedure. 6. Any condition that required the transfer of a patient to a hospital licensed under Chapter 395, F.S., from any facility or any

office maintained by an osteopathic physician for the practice of medicine which is not licensed under Chapter 395, F.S. (b) “Licensee” for purposes of this rule, includes an osteopathic physician or physician assistant issued a license, registration,

or certificate, for any period of time, pursuant to Chapter 459, F.S. (c) “Office maintained by an osteopathic physician” as that term is used in Section 459.026(1), F.S., is defined as a business

location where the osteopathic physician delivers medical services regardless of whether other physicians are practicing at the same location or the business is non-physician owned.

(2) Incident Reporting System. An incident reporting system shall be established for each osteopathic physician office. (a) Incident Reports. The incident reporting system shall include the prompt, postmarked and sent by certified mail within 15

calendar days after the occurrence of the adverse incident, reporting of incidents to the Department of Health, Consumer Services Unit, Post Office Box 14000, Tallahassee, Florida 32317-4000. The report shall be made on the Physician Office Adverse Incident Report, Form # DH-MQA 1030- created 2-00; revised 9-6-01, incorporated herein by reference, effective 2-12-02. The form can be obtained from the Board office. The report must be submitted by every licensee who was involved in the adverse incident. If multiple licensees are involved in the adverse incident, they may meet this requirement by signing off on one report; however, each signee is responsible for the accuracy of the report. This report shall contain the following information:

1. The patient’s name, locating information, gender, age, diagnosis, date of office visit, and purpose of office visit. 2. A clear and concise description of the incident including time, date, and exact location within the office. 3. A listing of all persons then known to be involved directly in the incident, including license numbers and locating

information, and a description of the person’s exact involvement and actions. 4. A listing of any witnesses not previously identified in 3. 5. The name, license number, locating information, and signature of the osteopathic physician or licensee submitting the report,

along with date and time that the report was completed. (b) Incident Report Review and Analysis. Evidence of compliance with this paragraph will be considered in mitigation in the

event the Board takes disciplinary action. 1. The osteopathic physician shall be responsible for the regular and systematic reviewing of all incident reports filed by the

osteopathic physician or physician assistant under the osteopathic physician’s supervision, for the purpose of identifying factors that contributed to the adverse incident and identifying trends or patterns as to time, place, or persons. The osteopathic physician shall implement corrective actions and incident prevention education and training indicated by the review of each adverse incident and upon emergence of any trend or pattern in incident occurrence.

2. Copies of incident reports shall be maintained in the osteopathic physician office. (3) Death reports. Notwithstanding the provisions of this rule and Section 459.026, F.S., an adverse incident which results in

death shall be reported immediately to the medical examiner pursuant to Section 406.12, F.S.

Specific Authority 459.005(1), 459.026(6) FS. Law Implemented 459.026 FS. History–New 2-12-02.

64B15-14.0076 Requirement for Osteopathic Physician Office Registration; Inspection or Accreditation. (1) Registration. (a) Every Florida licensed osteopathic physician who holds an active Florida license and performs Level II surgical procedures

in Florida with a maximum planned duration of five (5) minutes or longer or any Level III office surgery, as fully defined in Rule 64B15-14.007, F.A.C., shall register with the Board of Osteopathic Medicine on the following form which may be obtained from the Board office at 4052 Bald Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256 or by calling (850) 245-4161: Florida Board of Osteopathic Medicine Office Surgery Registration Program, DH-MQA 1071, 1/03, effective 11/20/03. It is the osteopathic physician’s responsibility to ensure that every office in which he or she performs Levels II or III surgical procedures as described above is registered, regardless of whether other physicians are practicing in the same office or whether the office is non-physician owned.

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(b) In order to register an office for surgical procedures, the osteopathic physician must provide to the Board of Osteopathic Medicine, his or her name, mailing address, Florida license number, and a list of each office where the covered surgical procedures are going to be performed by the osteopathic physician. The list shall also include each office name, address, telephone number, and level of surgery being performed at that location by the osteopathic physician; and if more than one physician is practicing at that location, a list of all physicians and levels of surgery being performed must be provided. The list shall also include the name of each physician assistant, ARNP and CRNA involved in the office surgery or anesthesia; copies of any protocols necessary for the supervision of any ARNP or CRNA; and any transfer agreements with local hospitals. In addition, the osteopathic physician shall submit a statement of compliance with Rule 64B15-14.007, F.A.C., when registering with the Department.

(c) The osteopathic physician must immediately notify the Board office, in writing, of any changes to the registration information.

(d) The registration shall be posted in the office. (2) Inspection. (a) Unless the osteopathic physician has previously provided written notification of current accreditation by a nationally

recognized accrediting agency or an accrediting organization approved by the Board the osteopathic physician shall submit to an annual inspection by the Department. Nationally recognized accrediting agencies are the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (AAAHC), Joint Commission on Accreditation for Ambulatory Healthcare Organizations (JCAHO), American Osteopathic Association (AOA), and AOA Healthcare Facilities Accreditation Program (HFAP). All nationally recognized and Board-approved accrediting organizations shall be held to the same Board-determined surgery and anesthesia standards for accrediting Florida office surgery sites.

(b) The initial inspection conducted pursuant to this rule shall be announced at least one week in advance of the arrival of the inspector(s).

(c) The Department shall determine compliance with the requirements of Rule 64B15-14.007, F.A.C. (d) If the office is determined to be in noncompliance, the osteopathic physician shall be notified and shall be given a written

statement at the time of inspection. Such written notice shall specify the deficiencies. Unless the deficiencies constitute an immediate and imminent danger to the public, the osteopathic physician shall be given 30 days from the date of inspection to correct any documented deficiencies and notify the Department of corrective action. Upon written notification from the osteopathic physician that all deficiencies have been corrected, the Department is authorized to reinspect for compliance.

(e) The deficiency notice and subsequent documentation shall be reviewed for consideration of disciplinary action. Documentation of corrective action shall be considered in mitigation of any offense.

(f) Nothing herein shall limit the authority of the Department to investigate a complaint without prior notice. (3) Accreditation. (a) The osteopathic physician shall submit written notification of the current accreditation survey of his or her office(s) from a

nationally recognized accrediting agency or an accrediting organization approved by the Board in lieu of undergoing an inspection by the Department.

(b) An osteopathic physician shall submit, within thirty (30) days of accreditation, a copy of the current accreditation survey of his or her office(s) and shall immediately notify the Board of Osteopathic Medicine of any accreditation changes that occur. For purposes of initial registration, an osteopathic physician shall submit a copy of the most recent accreditation survey of his or her office(s) in lieu of undergoing an inspection by the Department.

(c) If a provisional or conditional accreditation is received, the osteopathic physician shall notify the Board of Osteopathic Medicine in writing and shall include a plan of correction.

Specific Authority 459.005(1), (2) FS. Law Implemented 456.069, 459.005(2) FS. History–New 2-12-02, Amended 11-20-03.

64B15-14.0077 Approval of Osteopathic Physician Office Accrediting Organizations. (1) Definitions. (a) “Accredited” means full accreditation granted by a Board approved accrediting agency or organization. “Accredited” shall

also mean provisional accreditation provided that the office is in substantial compliance with the accrediting agency or organization’s standards; any deficiencies cited by the accrediting agency or organization do not affect the quality of patient care, and the deficiencies will be corrected within six months of the date on which the office was granted provisional accreditation.

(b) “Approved accrediting agency or organization” means nationally recognized accrediting agencies: American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (AAAHC) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO), American Osteopathic Association (AOA), and AOA Healthcare Facilities Accreditation Program (HFAP). Approved organizations also include those approved by the Board after submission of an application for approval pursuant to this rule.

(c) “Department” means the Department of Health. (2) Application. An application for approval as an accrediting organization shall be filed with the Board office at 4052 Bald

Cypress Way, Bin #C06, Tallahassee, Florida 32399-3256, and shall include the following information and documents: (a) Name and address of applicant;

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(b) Date applicant began to operate as an accrediting organization; (c) Copy of applicant’s current accreditation standards; (d) Description of accreditation process, including composition and qualification of accreditation surveyors; accreditation

activities; criteria for determination of compliance; and deficiency follow-up activities; (e) A list of all osteopathic physician offices located in Florida that are accredited by the applicant, if any. If there are no

accredited Florida physician offices, but there are accredited offices outside Florida, a list of the accredited offices outside of Florida is required;

(f) Copies of all incident reports filed with the state; (g) Statement of compliance with all requirements as specified in this rule. (3) Standards. The standards adopted by an accrediting organization for surgical and anesthetic procedures performed in a

physician office shall meet or exceed provisions of Chapters 456 and 459, F.S., and rules promulgated thereunder. Standards shall require that all health care practitioners be licensed or certified to the extent required by law.

(4) Requirements. In order to be approved by the Board, an accrediting organization must comply with the following requirements:

(a) The accrediting agency must have a mandatory quality assurance program approved by the Board of Osteopathic Medicine. (b) The accrediting agency must have anesthesia-related accreditation standards and quality assurance processes that are

reviewed and approved by the Board of Osteopathic Medicine. (c) The accrediting agency must have ongoing anesthesia-related accreditation and quality assurance processes involving the

active participation or anesthesiologists. (d) Accreditation periods shall not exceed three years. (e) The accrediting organization shall obtain authorization from the accredited entity to release accreditation reports and

corrective plans to the Board. The accrediting organization shall provide a copy of any accreditation report to the Board office within 30 days of completion of accrediting activities. The accrediting organization shall provide a copy of any corrective action plans to the Board office within 30 days of receipt from the physician office.

(f) If the accrediting agency or organization finds indications at any time during accreditation activities that conditions in the physician office pose a potential immediate jeopardy to patients, the accrediting agency or organization will immediately report the situation to the Department.

(g) An accrediting agency or organization shall send to the Board any change in its accreditation standards within 30 calendar days after making the change.

(h) An accrediting agency or organization shall comply with confidentiality requirements regarding protection of patient records.

(5) Renewal of Approval of Accrediting Organizations. Every accrediting organization approved by the Board pursuant to this rule is required to renew such approval every 3 years. Each written submission shall be filed with the Board at least three months prior to the third anniversary of the accrediting organization’s initial approval and each subsequent renewal of approval by the Board. Upon review of the submission by the Board, written notice shall be provided to the accrediting organization indicating the Board’s acceptance of the certification and the next date by which a renewal submission must be filed or of the Board’s decision that any identified changes are not acceptable and on that basis denial of renewal of approval as an accrediting organization.

(6) Any person interested in obtaining a complete list of approved accrediting organizations may contact the Board of Osteopathic Medicine or Department of Health.

Specific Authority 459.005(2) FS. Law Implemented 459.005(2) FS. History–New 2-12-02.

64B15-14.008 Standards for Telemedicine Practice. (1) Prescribing medications based solely on an electronic medical questionnaire constitutes the failure to practice osteopathic

medicine with that level of care, skill, and treatment which is recognized by reasonably prudent osteopathic physicians as being acceptable under similar conditions and circumstances, as well as prescribing legend drugs other than in the course of an osteopathic physician’s professional practice. Such practice shall constitute grounds for disciplinary action pursuant to Sections 459.015(1)(x) and (t), F.S.

(2) Osteopathic Physicians shall not provide treatment recommendations, including issuing a prescription, via electronic or other means, unless the following elements have been met:

(a) A documented patient evaluation, including history and physical examination, adequate to establish the diagnosis for which any drug is prescribed.

(b) Sufficient dialogue between the osteopathic physician and the patient regarding treatment options and the risks and benefits of treatment.

(c) Maintenance of contemporaneous medical records meeting the requirements of Rule 64B15-15.004, F.A.C. (3) The provisions of this rule are not applicable in an emergency situation. For purposes of this rule an emergency situation

means those situations in which the prescribing physician determines that the immediate administration of the medication is necessary for the proper treatment of the patient, and that it is not reasonably possible for the prescribing physician to comply with the provision of this rule prior to providing such prescription.

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(4) The provisions of this rule shall not be construed to prohibit patient care in consultation with another physician who has an ongoing relationship with the patient, and who has agreed to supervise the patient’s treatment, including the use of any prescribed medications, nor on-call or cross-coverage situations in which the physician has access to patient records.

Specific Authority 459.005, 459.015(1)(z) FS. Law Implemented 459.015(1)(x), (t) FS. History–New 10-16-01.

64B15-14.009 Standards for Office Based Opioid Addiction Treatment. (1) Treatment Principles. (a) The Board of Osteopathic Medicine recognizes that the prevalence of addiction to heroin and other opioids has risen

sharply in the United States and that the people of the State of Florida should have access to modern, appropriate and effective addiction treatment. The appropriate application of up-to-date knowledge and treatment modalities can successfully treat patients who suffer from opioid addiction and reduce the morbidity, mortality and costs associated with opioid addiction, as well as public health problems such as HIV, HBV, HCV and other infectious diseases. The Board encourages osteopathic physicians to assess their patients for a history of substance abuse and potential opioid addiction. The Board has developed these guidelines in an effort to balance the need to expand treatment capacity for opioid addicted patients with the need to prevent the inappropriate, unwise or illegal prescribing of opioids.

(b) The Board is obligated under the laws of the State of Florida to protect the public health and safety. The Board recognizes that inappropriate prescribing of controlled substances, including opioids, may lead to drug diversion and abuse by individuals who seek them for other than legitimate medical use. Physicians must be diligent in preventing the diversion of drugs for illegitimate and non-medical uses.

(c) Qualified physicians need not fear disciplinary action from the Board or other state regulatory or enforcement agency for appropriate prescribing, dispensing or administering approved opioid drugs in Schedule III, IV, or V, or combinations thereof, for a legitimate medical purpose in the usual course of opioid addiction treatment. The Board will consider appropriate prescribing, ordering, administering, or dispensing of these medications for opioid addiction to be for a legitimate medical purpose if based on accepted scientific knowledge of the treatment of opioid addiction and in compliance with applicable state and federal law.

(d) The Board will determine the appropriateness of prescribing based on the physician’s overall treatment of the patient and on available documentation of treatment plans and outcomes. The goal is to document and treat the patient’s addiction while effectively addressing other aspects of the patient’s functioning, including physical, psychological, medical, social and work-related factors. The following guidelines are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of accepted professional practice.

(2) Definitions. (a) Addiction. For the purposes of this rule “addiction” is defined as a primary, chronic, neurobiologic disease, with genetic,

psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm and craving.

(b) Agonists. For the purposes of this rule “agonist” drugs are substances that bind to the receptor and produce a response that is similar in effect to the natural ligand that would activate it. Full mu opioid agonists activate mu receptors, and increasing doses of full agonists produce increasing effects. Most opioids that are abused, such as morphine and heroin are full mu opioid agonists.

(c) Approved Schedule III-V Opioids. For the purposes of this rule “approved schedule III-V opioids” are those drugs referred to by the Drug Addiction Treatment Act of 2002 as specifically approved by the FDA for treatment of opioid dependence or addiction.

(d) Antagonists. For the purposes of this rule “antagonists” bind to but do not activate receptors. They prevent the receptor from being activated by an agonist compound.

(e) Maintenance Treatment. For the purposes of this rule “maintenance treatment” means the dispensing for a period in excess of 21 days of an opioid medication(s) at stable dosage levels in the treatment of an individual for dependence upon heroin or other opioids.

(f) Opioid Dependence. For the purposes of this rule “opioid dependence” is a maladaptive pattern of substance use, leading to clinically significant impairment or distress, manifested by 3 or more of the following, occurring at any time in the same 12-month period:

1. A need for markedly increased amounts of the substance to achieve intoxication or desired effect or markedly diminished effect with continued use of the same amount of substance;

2. The characteristic withdrawal syndrome for the substance or the same (or closely related) substance is taken to relieve or avoid withdrawal symptoms;

3. The substance was taken in larger amounts or over a longer period of time than was intended; 4. There is a persistent desire or unsuccessful efforts to cut down or control substance use; 5. Significant time is spent on activities to obtain the substance, use the substance, or recover from its effects; 6. Important social, occupational, or recreational activities are discontinued or reduced because of substance use; 7. Substance use is continued despite knowledge of having a persistent physical or psychological problem that is caused or

exacerbated by the substance.

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(g) Opioid Drug. For the purposes of this rule “opioid drug or opiate” means any drug having an addiction-forming or addiction-sustaining liability similar to morphine or being capable of conversion into a drug having such addiction-forming or addiction sustaining liability.

(h) Opioid Treatment Program (OTP). For the purposes of this rule “Opioid treatment program means a licensed program or practitioner engaged in the treatment of opioid addicted patients with approved Schedule II opioids (methadone and/or LAAM) in a methadone clinic or narcotic treatment program.

(i) Partial Agonists. For the purposes of this rule “partial agonists” occupy and activate receptors. At low doses, like full agonists, increasing doses of the partial agonist produce increasing effects. However, unlike full agonists, the receptor-activation produced by a partial agonist reaches a plateau over which increasing doses do not produce an increasing effect. The plateau may have the effect of limiting the partial agonist’s therapeutic activity as well as its toxicity.

(j) Physical Dependence. For the purpose of this rule, “physical dependence” on a controlled substance is defined as a physiologic state of neuro-adaptation which is characterized by the emergence of a withdrawal syndrome if drug use is stopped or decreased abruptly, or if an antagonist is administered. Physical dependence is an expected result of opioid use. Physical dependence, by itself, does not equate with addiction.

(k) Tolerance. For the purpose of this rule, “tolerance” is defined as a physiologic state resulting from regular use of a drug in which an increased dosage is needed to produce the same effect, or a reduced effect is observed with a constant dose.

(l) Substance Abuse. For the purpose of this rule, “substance abuse” is defined as a maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one or more of the following, occurring within a 12-month period:

1. Recurrent substance use resulting in a failure to fulfill major role obligations at work, school, or home; 2. Recurrent substance use in situations in which it is physically hazardous; 3. Recurrent substance-related legal problems; 4. Continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the

effects of the substance. (3) Physician Qualifications. (a) Osteopathic physicians who consider office-based treatment of opioid addiction must be able to recognize the condition of

drug or opioid addiction and be knowledgeable about the appropriate use of opioid agonist, antagonist, and partial agonist medications;

(b) Demonstrate required qualifications as defined under and in accordance with the “Drug Addiction Treatment Act of 2000” (DATA) (Public Law 106-310, Title XXXV, Sections 3501 and 3502);

(c) Obtain a waiver from the Substance Abuse and Mental Health Services. Administration (SAMHSA), as authorized by the Secretary of HHS. For the purpose of this rule, “waiver” is a documented authorization from the Secretary of HHS issued by SAMHSA under the DATA that exempts qualified physicians from the rules applied to OTPs.

(d) Must have a valid DEA registration number and a DEA identification number that specifically authorizes such office-based treatment. If an osteopathic physician wishes to prescribe or dispense narcotic drugs for maintenance or detoxification treatment on an emergency basis in order to facilitate the treatment of an individual patient before the issuance of the special DEA identification number, the physician must notify SAMHSA and the DEA of the intent to provide such treatment.

(4) Qualifications for Waiver. (a) In order to qualify for a waiver, physicians must hold a current license in the State of Florida and, at a minimum, meet one

or more of the following conditions to be considered as qualified to treat opioid addicted patients in an office-based setting in this state:

1. Subspecialty board certification in addiction psychiatry from the American Board of Medical Specialties; 2. Subspecialty board certification in addiction medicine from the American Osteopathic Association; 3. Addiction certification from the American Society of Addiction Medicine; 4. Completion of not less than 8 hours of training related to the treatment and management of opioid-dependent patients

provided by the American Society of Addiction Medicine, the American Academy of Addiction Psychiatry, the American Medical Association, the American Osteopathic Association, the American Psychiatric Association, or other organization approved by the Board;

5. Participation as an investigator in one or more clinical trials leading to the approval of a narcotic drug in Schedule III, IV, or V or a combination of such drugs for treatment of opioid addicted patients, that is evidenced by a statement submitted to the Secretary of Health and Human Services by the sponsor of such approved drug.

(5) Guidelines. The Board has adopted the following guidelines when evaluating the documentation and treatment of opioid addiction under the Drug Addiction Treatment Act:

(a) Evaluation of the Patient. A recent, complete medical history and physical examination must be documented in the medical record. The medical record shall document the nature of the patient’s addiction(s), evaluate underlying or coexisting diseases or conditions, the effect on physical and psychological function, and history of substance abuse and any prior treatments.

(b) Treatment Plan. The written treatment plan shall state objectives that will be used to determine treatment success, such as freedom from intoxication, improved physical function, psychosocial function and compliance and shall indicate if any further diagnostic evaluations are planned, as well as mental health and/or substance abuse counseling, psychiatric management or other

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ancillary services including development and compliance with a recovery program. This plan shall be reviewed periodically. After treatment begins, the physician shall adjust drug therapy to the individual medical needs of each patient. Treatment goals, other treatment modalities or a rehabilitation program shall be evaluated and discussed with the patient. If possible, every attempt shall be made to involve significant others or immediate family members in the treatment process, with the patient’s consent. The treatment plan shall also contain contingencies for treatment failure.

(c) Informed Consent and Agreement for Treatment. The physician shall discuss the risks and benefits of the use of approved opioid medications with the patient and, with appropriate consent of the patient or when appropriate the patient’s agent. The patient shall receive opioids from only one physician and/or one pharmacy when possible. The physician shall employ the use of a written agreement between physician and patient or patient’s agent addressing such issues as:

1. Alternative treatment options; 2. Regular toxicologic testing for drugs of abuse and therapeutic drug levels (if available and indicated); 3. Number and frequency of all prescription refills; and 4. Reasons for which drug therapy may be discontinued (i.e., violation of agreement). (d) Periodic Patient Evaluation. Patients shall be seen at reasonable intervals (at least weekly during initial treatment) based

upon the individual circumstance of the patient. Periodic assessment is necessary to determine compliance with the dosing regimen, effectiveness of treatment plan, and to assess how the patient is responding to the prescribed medication. Once a stable dosage is achieved and urine (or other toxicologic) tests are free of illicit drugs, less frequent office visits may be initiated (monthly may be reasonable for patients on a stable dose of the prescribed medication(s) who are making progress toward treatment objectives). Continuation or modification of opioid therapy shall depend on the physician’s evaluation of progress toward stated treatment objectives such as:

1. Absence of toxicity; 2. Absence of medical or behavioral adverse effects; 3. Responsible handling of medications; 4. Compliance with all elements of the treatment plan (including recovery-oriented activities, psychotherapy and/or other

psychosocial modalities); and 5. Abstinence from illicit drug use. If reasonable treatment goals are not being achieved, the physician shall re-evaluate the

appropriateness of continued treatment or modification. (e) Consultation. The physician shall refer the patient as necessary for additional evaluation and treatment in order to achieve

treatment objectives. The physician shall pursue a team approach to the treatment of opioid addiction, including referral for counseling and other ancillary services. Ongoing communication between the physician and consultants is necessary to ensure appropriate compliance with the treatment plan. This may be included in the formal treatment agreement between the physician and patient. Special attention shall be given to those patients who are at risk for misusing their medications and those whose living or work arrangements pose a risk for medication misuse or diversion. The management of addiction in patients with comorbid psychiatric disorders requires extra care, monitoring, documentation and consultation with or referral to a mental health professional.

(f) Medical Records. The medical record shall document the suitability of the patient for office-based treatment based upon the standard of care. Records shall remain current and be maintained in an accessible manner and readily available for review. The physician must adhere to confidentiality requirements which apply to the treatment of drug and alcohol addiction, including the prohibition against release of records or other information, except pursuant to a proper patient consent or court order, or in cases of true medical emergency or for the mandatory reporting of child abuse. The prescribing physician must keep accurate and complete records to include:

1. The medical history and physical examination; 2. Diagnostic, therapeutic and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed and/or dispensed to each patient); 8. A physical inventory of all Schedules III, IV, and V controlled substances on hand that are dispensed by the physician in the

course of maintenance or detoxification treatment of an individual; 9. Instructions and agreements; and 10. Periodic reviews.

Specific Authority 459.005, 459.015(1)(z) FS. Law Implemented 459.015(1)(z) FS. History–New 4-19-04.

64B15-14.010 Physician Practice Standard Regarding Do Not Resuscitate (DNR) Orders. Resuscitation may be withheld or withdrawn from a patient by a treating physician licensed pursuant to Chapter 459, F.S., if evidence of an order not to resuscitate by the patient’s physician is presented to the treating physician. An order not to resuscitate, to be valid, must be on the form as set forth in Section 401.45, F.S. The form must be signed by the patient’s physician and by the

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patient, or, if the patient is incapacitated, the patient’s health care surrogate, or proxy as provided in Chapter 765, F.S.; court appointed guardian as provided in Chapter 744, F.S.; or attorney in fact under a durable power of attorney as provided in Chapter 709, F.S. The court appointed guardian or attorney in fact must have been delegated authority to make health care decisions on behalf of the patient.

Specific Authority 459.015(1)(z) FS. Law Implemented 459.015(1)(z) FS. History–New 2-9-05.

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CHAPTER 64B15-15 MEDICAL RECORDS

64B15-15.001 Medical Records of Deceased Physician; Retention; Time Limitations. 64B15-15.002 Handling of Patient Records Upon Termination of Practice. 64B15-15.003 Patient Records; Costs of Reproduction; Timely Release. 64B15-15.004 Written Records; Minimum Content; Retention. 64B15-15.006 Maintenance/Ownership of Patient Records.

64B15-15.001 Medical Records of Deceased Physician; Retention; Time Limitations. (1) The executor, administrator, personal representative or survivor of a deceased osteopathic physician licensed pursuant to

Chapter 459, F.S., shall retain medical records in existence upon the death of the osteopathic physician concerning any patient of the osteopathic physician for at least a period of two (2) years from the date of the death of the physician.

(2) Within one (1) month from the date of death of the osteopathic physician, the executor, administrator, personal representative or survivor of the deceased osteopathic physician shall cause to be published in the newspaper of greatest general circulation in the county where the osteopathic physician resided, a notice indicating to the patients of the deceased osteopathic physician, that the osteopathic physician’s medical records are available to the patients or their duly constituted representative from a specific person at a certain location.

Specific Authority 456.058, 459.005 FS. Law Implemented 456.058 FS. History–New 7-1-80, Formerly 21R-15.01, Amended 7-19-89, Formerly 21R-15.001, 61F9-15.001, 59W-15.001, Amended 12-22-97.

64B15-15.002 Handling of Patient Records Upon Termination of Practice. (1) When an osteopathic physician sells or otherwise voluntarily terminates practice, the physician shall notify patients of such

termination by causing to be published, in the newspaper of greatest general circulation in the county of practice, a notice which shall contain the date of termination and an address at which the records may be obtained.

(2) When a physician’s practice is involuntarily terminated by suspension, emergency or otherwise, the physician shall immediately notify patients of such termination by causing to be published, in the newspaper of greatest general circulation in the county of practice, a notice which shall contain the date of termination and an address at which the records may be obtained. A copy of the notice shall be mailed to the board office within ten days of publication.

(3) In addition to the requirements of subsections (1) and (2) above, the physician shall place in a conspicuous location in or on the facade of the office a sign, announcing the termination of the practice. The sign shall be placed 30 days prior to the termination, when such termination is voluntary, and shall remain until the termination date. When the termination of practice is involuntary, the physician shall immediately cause the sign to be placed and shall remain in place for 30 days.

(4) For purposes of this rule, voluntary termination shall include retirement or relocation of the physician’s practice. Involuntary termination shall include suspension, revocation, relinquishment, or expiration of the physician’s license to practice osteopathic medicine.

(5) Both the notice and sign shall advise the physician’s patients of their opportunity to transfer or receive their records. (6) For purposes of this rule, an osteopathic physician may ask the Board to be exempt from this rule when relocation occurs in

the general area of the practice. (7) The osteopathic physician shall provide for the retention of medical records in existence concerning any patient of the

osteopathic physician for at least a period of two (2) years from the date his practice is sold or otherwise terminated. In the event that the osteopathic physician does not personally retain the medical records, then he shall publish a notice in the newspaper of greatest general circulation in the county in which he practiced immediately preceding termination of his practice, which shall provide the address at which the records shall be retained for the two (2) year period.

(8) Physicians whose patient records are maintained by an institution or health care entity formed under Chapter 641, F.S., shall be exempt from this rule.

(9) Nothing herein precludes a licensee of this Board from receiving records and delivering the records to the patient upon receipt of authorization to release the records.

Specific Authority 456.057, 459.0122 FS. Law Implemented 456.057, 459.0122 FS. History–New 5-13-87, Amended 7-19-89, Formerly 21R-15.002, Amended 1-10-94, Formerly 61F9-15.002, Amended 4-9-95, Formerly 59W-15.002.

64B15-15.003 Patient Records; Costs of Reproduction; Timely Release. (1) Any Osteopathic Physician who makes an examination of or administers treatment to any person shall upon request of such

person or his/her legal representative release copies of all reports and patient medical records made of such examination or treatment, including x-rays and insurance information. The furnishing of such copies shall not be conditioned upon payment of an unpaid or disputed fee for services rendered, but may be conditioned upon payment by the requesting party of the reasonable costs of reproducing the records.

(2) Reasonable costs of reproducing copies of written or typed documents or reports shall be as follows: (a) For the first 25 pages, the cost shall be no more than $1.00 per page.

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(b) For each page in excess of 25 pages, the cost shall be no more than 25 cents. (3) Reasonable costs of reproducing x-rays, and such other special kinds of records shall be the actual costs. The phrase “actual

costs” means the cost of the material and supplies used to duplicate the record, as well as the labor costs and overhead costs associated with such duplication.

(4) An Osteopathic Physician shall comply with a patient's written request for copies of records and reports in a timely manner, with due regard for the patient's health needs. In the absence of circumstances beyond the control of the licensee, timely shall mean less than 30 days.

Specific Authority 456.057, 459.005 FS. Law Implemented 456.057 FS. History–New 10-28-91, Formerly 21R-15.003, 61F9-15.003, 59W-15.003, Amended 4-30-03.

64B15-15.004 Written Records; Minimum Content; Retention. (1) For the purpose of implementing the provisions of subsection 459.015(1)(o), F.S., osteopathic physicians shall maintain

written legible records on each patient. Such written records shall contain, at a minimum, the following information about the patient:

(a) Patient histories; (b) Examination results; (c) Test results; (d) Records of drugs prescribed, dispensed or administered; (e) Reports of consultations; and (f) Reports of hospitalizations. (2) Whenever patient records are released or transferred, the osteopathic physician releasing or transferring the records shall

maintain either the original records or copies thereof and a notation shall be made in the retained records indicating to whom the records were released or transferred. However, whenever patient records are released or transferred directly to another Florida licensed physician, or licensed health care provider it is sufficient for the releasing or transferring osteopathic physician to maintain a listing of each patient whose records have been so released or transferred which listing also includes the physician or licensed health care provider to whom such records were released or transferred. Such listing shall be maintained for a period of five (5) years.

(3) In order that the patients may have meaningful access to their records pursuant to Section 455.241, F.S., an osteopathic physician shall maintain the written record of a patient for a period of at least five (5) years from the date the patient was last examined or treated by the osteopathic physician. However, upon the death of the osteopathic physician, the provisions of Rule 64B15-15.001, F.A.C., are controlling.

Specific Authority 459.005 FS. Law Implemented 456.058, 459.015(1)(o) FS. History–New 11-30-94, Amended 10-25-95, Formerly 59W-15.004, Amended 12-22-97.

64B15-15.006 Maintenance/Ownership of Patient Records. (1) The records required in this section and any other patient records shall be properly annotated to identify the physician of

record. The physician of record is the physician who: (a) Is noted in the patient record as the physician of record; or (b) Provides a treatment or service and is noted in the patient record as the physician of record for that treatment or service; or (c) If there has been more than one provider of treatment, does the surgical procedure, makes the diagnosis or finishes the

service or procedure in question; or (d) If there has been more than one provider of treatment and neither paragraph (a) or (b) can be determined with reasonable

certainty, is the owner physician of the practice in which the patient was seen or treated. However, in situations where the physician is employed by a Health Maintenance Organization (HMO), Corporation, Professional Association, or has entered into a contractual arrangement with state-chartered regional organizations known as Community Health Purchasing Alliances or CHPAs, the employing entity owns the records.

(2) All patient records required by this rule and any additional records maintained in the course of treatment shall be the property of the owner physician or the employing entity as noted in paragraph (1)(d).

(3) The owner physician or the employing entity are ultimately responsible for all record keeping requirements set forth by statute or rule.

Specific Authority 459.005, 459.015(1)(o) FS. Law Implemented 456.057, 459.015(1)(o) FS. History–New 11-30-94, Formerly 59W-15.006.

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CHAPTER 64B15-16 RESIDENT INTERNSHIP

64B15-16.001 Resident Internship Defined. 64B15-16.002 Procedure.

64B15-16.001 Resident Internship Defined. For purposes of determining compliance with the resident internship requirement of Section 459.006, Florida Statutes, for an applicant seeking licensure by examination, the Board defines the term “resident internship” to include both an approved residency and an internship in an approved hospital.

Specific Authority 459.005 FS. Law Implemented 459.006 FS. History–New 10-24-84, Formerly 21R-16.01, 21R-16.001, 61F9-16.001, 59W-16.001.

64B15-16.002 Procedure. (1) Any applicant who has failed to complete an AOA (American Osteopathic Association)-approved internship must apply to

the AOA for approval of the PGY (post-graduate year)-1 year of the ACGME (Accreditation Council on Graduate Medical Education) residency for educational equivalence. Upon acceptance of the PGY-1 year for educational equivalence of the ACGME residency by the AOA, the Board of Osteopathic Medicine will approve for licensure applicants who are otherwise qualified for licensure, and who demonstrate good cause as delineated below for having taken the ACGME residency in lieu of an AOA internship.

(2) When the AOA denies educational equivalency, the Board of Osteopathic Medicine will not review the equivalency of the PGY-1 year.

(3) When the AOA approves the ACGME residency’s PGY-1 year for educational equivalency and denies the demonstration of good cause for having taken the ACGME residency, the Board of Osteopathic Medicine shall review the applicant’s demonstration of good cause. Good cause for having taken a non-AOA approved rotating internship shall be:

(a) Personal limitation created by a documented physical or medical disability. (b) Unique documented opportunity otherwise unavailable that meets a practice area of critical need. (c) Documented legal restriction which requires physical presence in a particular state or local area. (d) Documented unusual or exceptional family circumstances which limit training opportunities. (e) Previous program met all AOA requirements but, due to documented circumstances beyond the control of the applicant,

was discontinued. (f) Documented inability to relocate to another geographic area without undue hardship. (g) Documented inability to obtain an AOA rotating internship. (4) Any applicant who completes an ACGME-approved residency shall be deemed to have met the educational equivalence of

an AOA rotating internship. It shall remain the responsibility of the applicant to demonstrate good cause, as defined above, for having not taken an AOA-approved internship.

Specific Authority 459.005, 459.006(1), 459.007(1) FS. Law Implemented 459.006(1), 459.007(1) FS. History–New 7-15-96, Formerly 59W-16.002, Amended 2-13-01.

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CHAPTER 64B15-18 PRESCRIPTIONS OF CERTAIN MEDICINAL DRUGS BY PHARMACISTS

64B15-18.001 Purpose and Effect. 64B15-18.002 General Terms and Conditions to be Followed by a Pharmacist When Ordering and Dispensing

Approved Medicinal Drug Products. 64B15-18.003 Medicinal Drugs Which May be Ordered by Pharmacists. 64B15-18.004 Fluoride Containing Products.

64B15-18.001 Purpose and Effect. The purpose of this rule chapter is to set forth pursuant to the requirements of Section 465.186, F.S., the medicinal drug products which may be ordered and dispensed by pharmacists to the public and to set forth the terms and conditions under which such ordering and dispensing by the pharmacist may take place. The list of drugs set forth below and the conditions under which said drugs may be ordered and dispensed have been determined pursuant to a joint committee of medical, osteopathic and pharmacy professionals as created by Section 465.186, F.S.

Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History–New 5-1-86, Formerly 21R-18.001, 61F9-18.001, 59W-18.001.

64B15-18.002 General Terms and Conditions to be Followed by a Pharmacist When Ordering and Dispensing Approved Medicinal Drug Products. Pharmacists may order the medicinal drug products set forth in each rule subject to the following terms and limitations:

(1) Injectable products shall not be ordered by the pharmacist. (2) No oral medicinal drugs shall be ordered by a pharmacist for a pregnant patient or nursing mother. (3) In any case of dispensing hereunder, the amount or quantity of drug dispensed shall not exceed a 34-day supply or standard

course of treatment unless subject to the specific limitations in this rule. Patients shall be advised that they should seek the advice of an appropriate health care provider if their present condition, symptom, or complaint does not improve upon the completion of the drug regimen.

(4) The directions for use of all prescribed medicinal drugs shall not exceed the manufacturer’s recommended dosage. (5) The pharmacist may only perform the acts of ordering and dispensing in a pharmacy which has been issued a permit by the

Board of Pharmacy. (6) The pharmacist shall create a prescription when ordering and dispensing medicinal drug products which shall be

maintained in the prescription files of the pharmacy. The pharmacist shall place the trade or generic name and the quantity dispensed on the prescription label, in addition to all other label requirements.

(7) The pharmacist shall maintain patient profiles, separate from the prescription order, for all patients for whom the pharmacist orders and dispenses medicinal drug products and shall initial and date each profile entry. Such profiles shall be maintained at the pharmacy wherein the ordering and dispensing originated for a period of seven (7) years.

(8) In the patient profiles, the pharmacist shall record as a minimum the following information if a medicinal drug product is ordered and dispensed.

(a) Patient’s chief complaint or condition in the patient’s own words. (b) A statement regarding the patient’s medical history. (c) A statement regarding the patient’s current complaint which may include, onset, duration and frequency of the problem. (d) The medicinal drug product ordered and dispensed. (e) The pharmacist ordering and dispensing the medicinal drug product shall initial the profile. (f) The prescription number shall be recorded in the patient’s profile. (9) A medicinal drug product may be ordered, and dispensed only by the pharmacist so ordering. (10) Only legend medicinal drugs may be prescribed by a pharmacist. Over-the-counter drugs are exempt from the

requirements of this rule and shall be recommended as over-the-counter products. (11) Pharmacy interns and supportive personnel may not be involved in the ordering of the medicinal drugs permitted in this

Rule.

Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History–New 5-1-86, Formerly 21R-18.002, 61F9-18.002, 59W-18.002.

64B15-18.003 Medicinal Drugs Which May be Ordered by Pharmacists. A Pharmacist may dispense from the following formulary, subject to the stated conditions:

(1) Oral analgesics. The following may be ordered for mild to moderate pain: magnesium salicylate/phenyltoloxamine citrate, acetylsalicylic acid (Zero order release, long acting tablets), choline salicylate and magnesium salicylate, IBUPROFEN (no more than 400 mg per dosage unit for minor pain and menstrual cramps limited to a six (6) day supply for one treatment). When appropriate, such prescriptions shall be labeled to be taken with food or milk.

(2) Urinary analgesics. The following may be ordered: phenazopyridine, not exceeding a two (2) day supply. Such prescriptions shall be labeled as to the tendency to discolor urine and when appropriate shall be labeled to be taken after meals.

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(3) Otic analgesics. The following may be dispensed: antipyrine 5.4%, benzocaine 1.4%, glycerin, which shall be labeled for use in the ear only.

(4) Hemorrhoid medications. The following may be dispensed: 0.5% hydrocortisone acetate and 0.5% dibucaine ointments and creams, limited to a seven (7) day supply.

(5) Leg cramps. The following may be ordered: quinine sulfate tablets, except to patients with cardiac arrhythmias, and not to patients currently using anticoagulant or digitalis containing drugs. When appropriate, such prescriptions shall be labeled to be taken with or after meals.

(6) Anti-nausea preparations. The following may be dispensed: Meclizine up to 25 mg., except for a patient currently using a central nervous system (CNS) depressant. The prescription shall be labeled to advise of drowsiness side effect and caution against use with alcohol or other depressants.

(7) Antihistamines and decongestants. The following, including their salts, either as a single ingredient product or in combination including nasal decongestants, may be ordered for patients above (6) years of age:

(a) Diphenhydramine. (b) Carbinoxamine. (c) Loratadine (maximum 14 days supply only). (d) Pyrilamine. (e) Azelastine. (f) Dexchlorpheniramine. (g) Brompheniramine. (h) Fexofenadine.

The patient should be warned that antihistamines should not be used by patients with bronchial asthma or other lower respiratory symptoms, glaucoma, cardiovascular disorders, hypertension, prostate conditions and urinary retention. Antihistamines shall be labeled to advise of drowsiness side effects and caution against use with alcohol or other depressants.

(i) Ephedrine. (j) Phenylephrine. (k) Phenyltoloxamine. (l) Azatadine. (m) Diphenylpyraline.

Oral decongestants shall not be ordered for use by patients with coronary artery disease, angina, hyperthyroidism, diabetes, glaucoma, prostate conditions, hypertension, or patients currently using monoamine oxidase inhibitors.

(8) Anthelmintic. The following may be ordered: Pyrantel pamoate. The drug product may only be ordered for use by patients over 2 years of age.

(9) Topical antifungal/antibacterials. The following may be ordered: Iodochlorhydroxyquin with 0.5% Hydrocortisone (not exceeding 20 grams), Haloprogin 1%, Clotrimazole topical cream and lotion. The patient shall be warned that all of the above products should not be used near deep or puncture wounds, and Iodochlorhydroxyquin preparations shall be labeled as to the staining potential.

(10) Topical anti-inflammatory. The following may be ordered: Preparations containing hydrocortisone not exceeding 0.5%. The patient shall be warned that hydrocortisone should not be used on bacterial or fungal infections or by patients with impaired circulation. Such prescriptions shall be labeled to avoid contact with eyes and broken skin.

(11) Otic antifungal/antibacterial. The following may be ordered: acetic acid 2% in aluminum acetate solution, which shall be labeled for use in ears only.

(12) Keratolytics. The following may be ordered: salicylic acid 16.7% and lactic acid 16.7% in flexible collodion, to be applied to warts, except for patients under two (2) years of age, and those with diabetes or impaired circulation. Prescriptions shall be labeled to avoid contact with normal skin, eyes and mucous membranes.

(13) Vitamins with fluoride (This does not include vitamins with folic acid in excess of 0.9 mg.). (14) Medicinal drug shampoos containing Lindane may be ordered pursuant to the following conditions: (a) The pharmacist shall limit the order to the treatment of head lice only and provide the patient with the appropriate

instructions and precautions for use. (b) The amount allowed per person shall be four ounces.

Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History–New 5-1-86, Formerly 21R-18.003, 61F9-18.003, 59W-18.003, Amended 10-16-01.

64B15-18.004 Fluoride Containing Products. Oral medicinal drug products containing fluoride may be ordered by pharmacists for their patients who do not have fluoride supplement in their drinking water, pursuant to the following limitations:

(1) The fluoride content of drinking water does not exceed 0.5 ppm. (2) Once a fluoride treatment has been initiated with one specific fluoride medicinal drug product it should not be interchanged

with a product of a different manufacturer for the course of the treatment.

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(3) If the fluoride content is less than 0.5 ppm then the following dosage schedule for oral usage shall be followed:(a)1. For ages 0-6 months.a. Less than 0.3 ppm in water – no supplementation. b. 0.3 – 0.6 ppm in water – no supplementation. c. 0.6 ppm in water – no supplementation. 2. For ages 6 months – 3 years. a. Less than 0.3 ppm in water – supplement with 0.25 mg. F/day. b. 0.3 – 0.6 ppm in water – no supplementation. c. 0.6 ppm in water – no supplementation. 3. For ages 3 – 6 years. a. Less than 0.3 ppm in water – supplement with 0.5 mg. F/day. b. 0.3 – 0.6 ppm in water – supplement with 0.25 mg. F/day. c. 0.6 ppm in water – no supplementation. 4. For ages 6-16 years. a. Less than 0.3 ppm in water – supplement with 1.00 mg. F/day. b. 0.3 – 0.6 ppm in water – supplement with 0.5 mg. F/day. c. 0.6 ppm in water – no supplementation. (b) No more than 264 mg. of sodium fluoride may be dispensed at any one time to a patient. (c) Notwithstanding the provisions of subsection 64B15-14.002(3), F.A.C., a pharmacist may continue a course of therapy

with fluoride products until appropriate referral to another health care practitioner is indicated or in no event shall the course of therapy be more than one (1) year.

Specific Authority 465.186(2) FS. Law Implemented 465.186 FS. History–New 5-1-86, Formerly 21R-18.004, 61F9-18.004, 59W-18.004, Amended 10-16-01.

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CHAPTER 64B15-19 DISCIPLINARY GUIDELINES

64B15-19.001 Purpose.64B15-19.002 Violations and Penalties.64B15-19.003 Aggravating or Mitigating Circumstances.64B15-19.004 Time for Payment of Civil Penalties.64B15-19.005 Probationary Conditions and Definitions.64B15-19.0055 Reinstatement of License.64B15-19.006 Supervision of Physician Assistant.64B15-19.007 Citations.64B15-19.008 Mediation.

64B15-19.001 Purpose. The board provides within this rule disciplinary guidelines which shall be imposed upon applicants or licensees whom it regulates under Chapter 459, F.S. The purpose of this rule is to notify applicants and licensees of the ranges of penalties which will routinely be imposed during a formal or informal hearing unless the board finds it necessary to deviate from the guidelines for the stated reasons given within this rule. Each range includes the lowest and highest penalty and all penalties falling between. For purposes of this rule, the order of penalties, ranging from lowest to highest, is: letter of concern; reprimand; probation; fine; restriction or certification with restrictions; suspension, revocation or refusal to certify. Pursuant to Section 459.015(2), F.S., combinations of these penalties are permissible by law. Nothing in this rule shall preclude any discipline imposed upon an applicant or licensee pursuant to a stipulation or settlement agreement, nor shall the ranges of penalties set forth in this rule preclude the probable cause panel from issuing a letter of guidance upon a finding of probable cause where appropriate.

Specific Authority 456.079, 459.005, 459.015(5) FS. Law Implemented 456.079 FS. History–New 9-30-87, Formerly 21R-19.001, 61F9-19.001, 59W-19.001, Amended 2-2-98, 11-12-00.

64B15-19.002 Violations and Penalties. In imposing discipline upon applicants and licensees, the board shall act in accordance with the following disciplinary guidelines and shall impose a penalty within the range corresponding to the violations set forth below. The statutory language is intended to provide a description of the violation and is not a complete statement of the violation; the complete statement may be found in the statutory provision cited directly under each violation description.

(1) Attempting to obtain, obtaining or renewing a

license or certificate by bribery, fraud or through

an error of the Department or board.

(456.072(1)(h) & 459.015(1)(a), F.S.)

MINIMUM MAXIMUM

FIRST OFFENSE: denial with ability to denial with ability to

reapply immediately reapply in not less

upon payment of than 3 years or

$5,000 fine or revocation and $7,500 fine

probation and

$5,000 fine

SECOND OFFENSE: denial with ability to denial of license with

ability to reapply in not less no ability to reapply or

than 3 years and $10,000 revocation and

fine or suspension to be $10,000 fine

followed by probation and

$10,000 fine

(2) Action taken against license by another jurisdiction.

(456.072(1)(f) & 459.015(1)(b), F.S.)

FIRST OFFENSE: imposition of discipline imposition of discipline

comparable to discipline comparable to discipline

that would have been that would have been

imposed in Florida if the imposed in Florida if the

substantive violation substantive violation

occurred in Florida and occurred in Florida and

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$1000 fine $5000 fine

SECOND OFFENSE: imposition of discipline revocation and $10,000

comparable to discipline fine or denial of

that would have been license until the

imposed in Florida if the licensee’s license is

substantive violation unencumbered in the

occurred in Florida and jurisdiction where

$5,000 fine disciplinary action was

originally taken

(3) Guilty of crime directly relating

to practice or ability to practice.

(456.072(1)(c) & 459.015(1)(c), F.S.)

FIRST OFFENSE: probation and $2,000 fine revocation and $5,000

fine or denial of license

with ability to reapply for

licensure in not less than

3 years

SECOND OFFENSE: suspension to be revocation and $10,000

followed by probation fine or permanent denial

and $5,000 fine of license

(4) False, deceptive, or misleading advertising.

(459.015(1)(d), F.S.)

FIRST OFFENSE: letter of concern reprimand and

$1,000 fine

SECOND OFFENSE: probation and $2,000 fine probation and $5,000 fine

THIRD OFFENSE: 3 month suspension to be 1 year suspension to be

followed by probation and followed by probation

$5,000 fine and $5,000 fine

(5) Failure to report another licensee in violation.

(456.072(1)(i) & 459.015(1)(e), F.S.)

FIRST OFFENSE: letter of concern reprimand and $1,000 fine

SECOND OFFENSE: reprimand and $2,500 fine probation and $2,500 fine

THIRD OFFENSE: probation and $5,000 fine suspension to be

followed by probation

and $5,000 fine

(6) Aiding unlicensed practice.

(456.072(1)(j) & 459.015(1)(f), F.S.)

FIRST OFFENSE: probation and $2,500 fine denial or revocation and

$5,000 fine

SECOND OFFENSE: suspension to be denial or revocation and

followed by probation and $10,000 fine

$5,000 fine

(7) Failure to perform legal duty or obligation.

(456.072(1)(k) & 459.015(1)(g), F.S.)

FIRST OFFENSE: reprimand and $1,000 fine denial with ability to

reapply after no less than

2 years or revocation and

$5,000 fine

SECOND OFFENSE: probation and $5,000 fine denial or revocation and

$10,000 fine

(8) Giving false testimony regarding the

practice of medicine.

(459.015(1)(h), F.S.)

FIRST OFFENSE: reprimand and $2,500 fine probation and $5,000 fine

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SECOND OFFENSE: suspension to be followed by revocation and $10,000

probation and $5,000 fine fine or denial of license

(9) Filing a false report or failing to file a report

as required.

(456.072(1)(l) & 459.015(1)(i), F.S.)

FIRST OFFENSE: reprimand and $5,000 fine suspension to be followed by probation and $10,000 fine or denial with ability to reapply in not less than 1 year

SECOND OFFENSE: denial with ability to reapply denial with no ability to

in not less than 3 years or reapply or revocation and

suspension to be followed $10,000 fine

by probation and $10,000 fine

(10) Kickbacks and unauthorized fee arrangements.

(459.015(1)(j), F.S.)

FIRST OFFENSE: probation and $2,500 fine denial or suspension to

be followed by probation

and $5,000 fine

SECOND OFFENSE: denial or suspension to denial or revocation and

be followed by probation a $10,000 fine

and $10,000 fine

(11) Failure to provide financial disclosure form to

a patient being referred to an entity in which the

referring physician is an investor.

(456.053, F.S.)

FIRST OFFENSE: reprimand reprimand and $2,500 fine

SECOND OFFENSE: reprimand and $5,000 fine probation and $5,000 fine

THIRD OFFENSE: probation and $7,500 fine suspension to be


and $10,000 fine

(12) Improper refusal to provide health care.

(459.015(1)(k), F.S.)


SECOND OFFENSE: suspension to be followed revocation and $10,000 fine


(13) Sexual misconduct within the patient

physician relationship.

(456.072(1)(u) & 459.015(1)(l), F.S.)

FIRST OFFENSE: probation and $10,000 fine denial of licensure

or revocation and

$10,000 fine

SECOND OFFENSE: suspension to be followed denial of licensure

by probation and $10,000 fine or revocation and

$10,000 fine

(14) Deceptive, untrue, or fraudulent

misrepresentations in the practice

of medicine.

(456.072(1)(a) & (m) & 459.015(1)(m), F.S.)

FIRST OFFENSE: reprimand and $10,000 fine denial of licensure or

suspension to be


and $10,000 fine

SECOND OFFENSE: denial of licensure or denial of licensure or

suspension to be revocation and $10,000 fine

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and $10,000 fine

(15) Improper solicitation of patients.

(459.015(1)(n), F.S.)

FIRST OFFENSE: reprimand and $5,000 fine

SECOND OFFENSE: suspension to be followed


(16) Failure to keep written medical records.

(459.015(1)(o), F.S.)




(17) Fraudulent, alteration or destruction of

patient records.

(459.015(1)(p), F.S.)

FIRST OFFENSE: probation and $5,000 fine



(18) Exercising improper influence on patient.

(456.072(1)(n) & 459.015(1)(q), F.S.)




(19) Improper advertising of pharmacy.

(459.015(1)(r), F.S.)

FIRST OFFENSE: letter of concern

SECOND OFFENSE: probation and $2,000 fine

THIRD OFFENSE: probation and $7,500 fine

(20) Performing, professional services not

authorized by patient.

(459.015(1)(s), F.S.)



(21) Controlled substance violations.

(459.015(1)(t), F.S.)




(22) Prescribing or dispensing of a scheduled drug

by the physician to himself.

(459.015(1)(u), F.S.)



probation and $5,000 fine

revocation and $10,000 fine



suspension to be


and $7,500 fine


suspension to be


and $7,500 fine


reprimand and

$1,000 fine


suspension to be


and $10,000 fine



suspension to be


and $7,500 fine


suspension to be


and $7,500 fine


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(23) Use of amygdalin (Laetrile).

(459.015(1)(v), F.S.)


SECOND OFFENSE: suspension to be followed revocation and $10,000 fine


(24) Inability to practice medicine with

skill and safety.

(459.015(1)(w), F.S.)

FIRST OFFENSE: denial or probation and denial or suspension until

$2,500 fine licensee is able to

demonstrate to the Board

ability to practice with

reasonable skill and

safety to be followed by


SECOND OFFENSE: denial or suspension until denial or revocation and

licensee is able to $10,000 fine

demonstrate to the Board

ability to practice with

reasonable skill and safety to

be followed by probation and

$7,500 fine

(25) Gross Malpractice.

(459.015(1)(x), F.S.)

FIRST OFFENSE: denial or probation and denial or revocation and

$7,500 fine $10,000 fine

SECOND OFFENSE: denial or suspension to be denial or revocation and


$7,500 fine

(26) Repeated Malpractice.

(459.015(1)(x), F.S.)

FIRST OFFENSE: denial or probation and denial or revocation and

$7,500 fine $10,000 fine



$7,500 fine

(27) Failure to practice with level of care, skill,

and treatment recognized by a reasonably

prudent physician as acceptable under similar

conditions and circumstances.

(459.015(1)(x), F.S.)

FIRST OFFENSE: denial or probation and denial or suspension to

$5,000 fine be followed by probation

and $7,500 fine



$7,500 fine

(28) Improper performing of experimental treatment.

(459.015(1)(y), F.S.)

FIRST OFFENSE: denial or reprimand and denial or suspension to

$5,000 fine be followed by probation

and $5,000 fine


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$7,500 fine

(29) Practicing beyond one’s scope.

(459.015(1)(z), F.S.)

FIRST OFFENSE: denial or reprimand and

$5,000 fine

SECOND OFFENSE: denial or suspension to be


$7,500 fine

(30) Delegation of professional responsibilities

to unqualified person.

(456.072(1)(p) & 459.015(1)(aa), F.S.)




$7,500 fine

(31) Violation of law, rule, order, or failure to

comply with subpoena.

(456.072(1)(q) & 459.015(1)(bb), F.S.)


$5,000 fine



$7,500 fine

(32) Restricting another from lawfully

advertising services.

(459.015(1)(cc), F.S.)



THIRD OFFENSE: 3 month suspension to be

followed by probation and a

$5,000 fine

(33) Procuring, aiding or abetting an

unlawful abortion.

(459.015(1)(dd), F.S.)




(34) Presigning blank prescription forms.

(459.015(1)(ee), F.S.)



(35) Prescribing a Schedule II substance

for office use.

(459.015(1)(ff), F.S.)


$10,000 fine

denial or suspension to


and $5,000 fine

denial or revocation and

$10,000 fine



and $5,000 fine


$10,000 fine



and $5,000 fine


$10,000 fine

reprimand and $1,000 fine


1 year suspension to be


and $5,000 fine

suspension to be


and $7,500 fine


suspension to be


and $5,000 fine


suspension to be

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SECOND OFFENSE:

(36) Improper use of Schedule II amphetamine

or sympathomimetic amine drug.

(459.015(1)(gg), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(37) Failure to adequately supervise

assisting personnel.

(459.015(1)(hh), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(38) Improper use of substances for muscle

building or enhancement of athletic

performance.

(459.015(1)(ii), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(39) Misrepresenting, concealing a material

fact during licensing, or disciplinary procedure.

(459.015(1)(jj), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(40) Improperly interfering with an investigation

or disciplinary proceeding.

(456.072(1)(r) & 459.015(1)(kk), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(41) Failing to report any licensee who has

violated the disciplinary act who provides

services at the same office.

(459.015(1)(ll), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

THIRD OFFENSE:



and $5,000 fine




suspension to be


and $5,000 fine




suspension to be


and $5,000 fine




suspension to be


and $5,000 fine


denial with ability to

reapply immediately

upon payment of

$5,000 fine or

probation and


reapply in not less

than 3 years or


$5,000 fine


reapply in not less

than 3 years and $10,000

fine or suspension to be


$10,000 fine

denial of license with

no ability to reapply or

revocation and

$10,000 fine


suspension to be followed


revocation and

$10,000 fine

revocation and

$10,000 fine

letter of concern





suspension to be

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(42) Giving corroborating written medical expert

opinion without reasonable investigation.

(459.015(1)(mm), F.S.)



(43) Failure to comply with guidelines for use

of obesity drugs.

(459.0135, F.S. & Rule 64B15-14.004, F.A.C.)



(44) Falsely advertising or holding oneself

out as a board-certified specialist.

(459.015(1)(nn), F.S.)




(45) Failing to provide patients with information

about their patient rights and how to file a complaint.

(456.072(1)(t) & 459.015(1)(oo), F.S.)




(46) Intentionally violating any rule adopted by the

board or the department.

(456.072(1)(b), F.S.)


$5,000 fine

SECOND OFFENSE: denial or probation and

$7,500 fine

(47) Using a Class III or a Class IV laser device

without having complied with the rules adopted

pursuant to Section 501.122(2), F.S.

(456.072(1)(d), F.S.)




(48) Failing to comply with the educational course

requirements for human immunodeficiency virus

and acquired immune deficiency syndrome.

(456.072(1)(e), F.S.)




(49) Having been found liable in a civil proceeding


and $10,000 fine

suspension to be


and $5,000 fine


suspension to be


and $5,000 fine






suspension to be


and $10,000 fine



and $5,000 fine

denial with no ability to

reapply or revocation and

$10,000 fine





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for knowingly filing a false report or complaint with

the department against another licensee.

(456.072(1)(g), F.S.)




(50) Failing to comply with the educational

course requirements for domestic violence.

(456.072(1)(s), F.S.)




(51) Failing to comply with the requirements for

profiling and credentialing.

(456.072(1)(v), F.S.)

FIRST OFFENSE: $2,500 fine


(52) Failing to report to the board in writing within

30 days after the licensee has been convicted or

found guilty of, or entered a plea of nolo contendere

to a crime in any jurisdiction.

(456.072(1)(w), F.S.)

FIRST OFFENSE: $5,000 fine


(53) Using information about people involved in

motor vehicle accidents which has been derived

from accident reports made by law enforcement

officers or persons involved in accidents pursuant

to Section 316.066, F.S., or using information published in

a newspaper or other news publication or through

a radio or television broadcast that has used

information gained from such reports, for the purposes

of commercial or any other solicitation whatsoever of the people involved in such accidents.

(456.072(1)(x), F.S.)




(54) Action taken against any license by

another jurisdiction.

(456.072(1)(f), F.S.)

FIRST OFFENSE: probation and $2,000

fine





suspension to be followed by



denial of licensure or

suspension to be


and $5,000 fine

denial of licensure with

no ability to reapply or


reprimand and

$1,000 fine


suspension to be


and $10,000 fine

revocation and $5,000

fine or denial of license

with ability to reapply for

licensure in not less than

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SECOND OFFENSE:

(55) Testing positive for any drug on any confirmed

preemployment or employer-ordered drug screening.

(456.072(1)(z), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(56) Performing or attempting to perform

health care services on the wrong patient,

a wrong procedure, an unauthorized,

unnecessary or unrelated procedure.

(456.072(1)(aa), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(57) Leaving a foreign body in a

patient such as a sponge, clamp,

forceps, surgical needle or other

paraphernalia.

(456.072(1)(bb), F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

(58) Being terminated from a treatment program for

impaired practitioners, as described in Section 456.076, F.S.,

for failure to comply, without good cause, with the

terms of the monitoring or treatment contract

entered into by the licensee, or for not successfully

completing any drug-treatment or alcohol-treatment

program. (456.072(1)(gg) F.S.)

FIRST OFFENSE:

SECOND OFFENSE:

suspension to be


and $5,000 fine


suspension to be followed

by probation and $7,500

fine

denial or probation and

$5,000 fine

denial or suspension and

$10,000 fine

denial or probation and

$5,000 fine

denial or suspension and

$10,000 fine

stayed suspension and


suspension until licensee is

able to demonstrate to the

Board ability to practice with

reasonable skill and safety to


and $7,500 fine.

3 years


fine or permanent denial

of license

suspension to be


and $7,500 fine


fine

denial or revocation

and $10,000 fine


and $10,000 fine


and $10,000 fine


and $10,000 fine

suspension until licensee is

able to demonstrate to

the Board ability to practice

with reasonable skill and

safety to be followed by



Specific Authority 456.079, 459.015(5) FS. Law Implemented 456.072, 456.079 FS. History–New 9-30-87, Amended 10-28-91, 1-12-93, Formerly 21R-19.002, 61F9-19.002, 59W-19.002, Amended 2-2-98, 2-11-01, 6-7-01, 2-26-02, 12-7-05.

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64B15-19.003 Aggravating or Mitigating Circumstances. When either the petitioner or respondent is able to demonstrate aggravating or mitigating circumstances to the board by clear and convincing evidence, the board shall be entitled to deviate from the above guidelines in imposing discipline upon an applicant or licensee. Absence of any such evidence of aggravating or mitigating circumstances before the hearing officer prior to the issuance of a recommended order shall not relieve the board of its duty to consider evidence of mitigating or aggravating circumstances. Aggravating and mitigating circumstances shall include, but not be limited to the following:

(1) The danger to the public; (2) The length of time since the violations; (3) The number of times the licensee has been previously disciplined by the Board; (4) The length of time the licensee has practiced; (5) The actual damage, physical or otherwise, caused by the violation; (6) The deterrent effect of the penalty imposed; (7) The effect of penalty upon the licensee’s livelihood; (8) Any effort of rehabilitation by the licensee; (9) The actual knowledge of the licensee pertaining to the violation; (10) Attempts by the licensee to correct or stop violations or refusal by licensee to correct or stop violations; (11) Related violations against licensee in another state, including findings of guilt or innocence, penalties imposed and

penalties served; (12) The actual negligence of the licensee pertaining to any violations; (13) The penalties imposed for related offenses; (14) The pecuniary gain to the licensee; (15) Any other relevant mitigating or aggravating factors under the circumstances. Any penalties imposed by the board may

not exceed the maximum penalties set forth in Section 459.015(2), F.S.

Specific Authority 456.079 FS. Law Implemented 456.079 FS. History–New 9-30-87, Formerly 21R-19.003, 61F9-19.003, 59W-19.003, Amended 7-13-04.

64B15-19.004 Time for Payment of Civil Penalties. In cases where the Board of Osteopathic Medicine imposes a civil penalty for violation of Chapter 456 or 459, F.S., or the rules promulgated pursuant thereunder, the penalty shall be paid within thirty (30) days of its imposition by Order of the Board unless stated otherwise in the Order.

Specific Authority 455.227(2), 459.005 FS. Law Implemented 455.227(2) FS. History–New 12-23-80, Formerly 21R-11.02, 21R-11.002, 21R-19.004, 61F9-19.004, 59W-19.004, Amended 11-12-00.

64B15-19.005 Probationary Conditions and Definitions. (1) Indirect Supervision. Whenever a license is placed on probation or otherwise restricted in such a manner as to require the

Respondent to practice under indirect supervision, the term indirect supervision does not require that the monitoring physician practice on the same premises as the Respondent; however, the monitor shall practice within a reasonable geographic proximity to Respondent, which shall be within 20 miles unless otherwise authorized by the Board, and shall be readily available for consultation.

(2) Direct Supervision. Whenever a license is placed on probation or otherwise restricted in such a manner as to require the Respondent to practice under direct supervision, the term direct supervision requires that the Respondent practice medicine only if the supervisor is on the premises.

(3) Provisions governing all supervised or monitored physicians. (a) The supervisor/monitor shall be furnished with copies of the Administrative Complaint, Final Order, Stipulation (if

applicable), and other relevant orders. (b) The Respondent shall not practice without a supervisor/monitor unless otherwise ordered by the Board. The Respondent

shall appear at the next meeting of the Board with his proposed supervisor or monitor unless otherwise ordered. (c) After the next meeting of the Board, Respondent shall only practice under the supervision of the supervisor or monitor. If

for any reason the approved supervisor/monitor is unwilling or unable to serve, Respondent and the supervisor/monitor shall immediately notify the Executive Director of the Board, and Respondent shall cease practice until a temporary supervisor/monitor is approved. The Chairman of the Board may approve a temporary supervisor/monitor who may serve in that capacity until the next meeting of the Board at which time the Board shall accept or reject a new proposed supervisor/monitor. If the Board rejects the proposed supervisor/monitor, Respondent shall cease practice until a new supervisor/monitor is approved by the Board.

(d) The supervisor/monitor must be a licensee under Chapter 459, F.S., in good standing and without restriction or limitation on his license. However, when no physician licensed under Chapter 459, F.S., is available to supervise/monitor a licensee, the Board shall approve a physician licensed under Chapter 458, F.S., provided that said licensee is willing to serve as a supervisor/ monitor. In addition, the Board may reject any proposed supervisor/monitor on the basis that he or she has previously been subject

- 216

to any disciplinary action against his or her license to practice osteopathic medicine in this or any other jurisdiction. The supervisor/ monitor must be actively engaged in the same or similar specialty area unless otherwise provided by the Board. The Board may also reject any proposed supervisor/monitor for good cause shown.

(4) For purposes of determining the dates when reports are due, the date the Final Order is filed shall constitute the beginning of the quarter.

(a) All quarterly reports shall be provided to the Board office no later than three months from the filing date of the Final Order. (b) All semiannual reports shall be provided to the Board office no later than six months from the filing date of the Final Order. (c) All annual reports shall be provided to the Board office no later than twelve months from the filing date of the Final Order.

Specific Authority 459.005 FS. Law Implemented 459.015(2)(g) FS. History–New 4-18-89, Formerly 21R-19.005, 61F9-19.005, Amended 9-5-94, Formerly 59W-19.005, Amended 11-27-97, 10-20-98, 11-2-05.

64B15-19.0055 Reinstatement of License. (1) No license to practice osteopathic medicine in Florida which was revoked by the Board after June 5, 1983, or which was

voluntarily relinquished after July 1, 1988, shall be subject to reinstatement unless leave to petition for reinstatement was specifically authorized in the final order. An osteopathic physician whose license was revoked or relinquished may, however, apply for relicensure unless, in the case of relinquishment, the osteopathic physician explicitly agreed never to reapply for licensure.

(2) When disciplinary action is taken against a licensee which results in the licensee’s being unable to use the license for a period of time for reasons including, but not limited to, suspension, inactivation, or other restriction, but not including revocation subsequent to June 5, 1983, the licensee may petition for reinstatement of the license as follows:

(a) When the suspension, inactivation, or restriction is for a definite period of time and is not based upon the osteopathic physician’s ability to safely engage in the practice of osteopathic medicine pursuant to Section 459.015(3), F.S., the license shall be reinstated upon expiration of the period of suspension if full compliance with the final order has been shown and the licensee has submitted documentation of completion of the continuing medical education requirements imposed on an active status licensee for all biennial licensure periods in which the licensee was suspended, inactive or under other restriction;

(b) When the suspension, inactivation, or other restriction is for a definite period of time, is based upon the osteopathic physician’s ability to safely engage in the practice of osteopathic medicine, or both, the licensee shall demonstrate to the Board at the expiration of the period of suspension, or immediately prior thereto, compliance with the terms and conditions of the final order, completion of the continuing medical education requirements imposed on an active status licensee for all biennial licensure periods in which the licensee was suspended, inactive or under other restriction, and, where applicable, the ability to safely engage in the practice of osteopathic medicine in order to obtain reinstatement. The Board shall consider reinstatement at either the Board meeting immediately preceding expiration or at any Board meeting subsequent thereto. If the licensee is able to demonstrate compliance with the terms of the final order and, where applicable, the ability to safely engage in the practice of osteopathic medicine, the Board shall reinstate the license.

(c) When the suspension, inactivation, or other restriction is for a definite period of time or for an indefinite period of time, the licensee may petition the Board to consider reinstatement of a license acted against for an indefinite period of time or early reinstatement of a license acted against for a definite period of time. When such a petition is filed, it must include all documentation of the petitioner’s compliance with the final order, completion of the continuing medical education requirements imposed on an active status licensee for all biennial licensure periods in which the licensee was suspended, inactive or under other restriction, petitioner’s ability to safely engage in practice, petitioner’s plan for the return to practice, and any other information which the petitioner would want the Board to consider if it grants the petition for consideration. If the plan for return to practice includes a period of supervised practice, the documentation should include the name of the proposed supervising physician and a written statement from the proposed supervising physician of his or her willingness to serve in that capacity. No oral testimony or personal appearance will be permitted at the time the Board hears a petition to consider reinstatement or early reinstatement. Upon the granting by the Board of the petition to consider such reinstatement or early reinstatement, the licensee shall, at a subsequent meeting, have an opportunity to demonstrate his or her ability to safely engage in the practice of osteopathic medicine and compliance with the terms of the final order. The Board shall reinstate the license upon a proper demonstration of competency and of compliance with the final order by the licensee.

(3) In order to demonstrate the ability to safely engage in the practice of osteopathic medicine, a licensee shall show compliance with all terms of the final order and may, in addition, present evidence of additional matters, including, but not limited to:

(a) Completion of continuing education courses approved by the Board; (b) Participation in medical educational programs, including post-graduate training, internships, residencies, or fellowships; (c) Submission of reports of mental or physical examination by appropriate professionals; (d) Completion of treatment within a program designed to alleviate alcohol, chemical, or drug dependencies, including

necessary aftercare measures or a plan for continuation of such treatment, as appropriate; (e) If action was taken against a Florida license based on action taken against the license or the authority to practice osteopathic

medicine by the licensing authority of another jurisdiction, proof that the licensee has a license in the jurisdiction which took action and that license is in good standing and unencumbered;

- 217

(f) If action was taken against the license based on conviction of, being found guilty of, or entry of a plea of nolo contendere to a crime, proof that all criminal sanctions imposed by the court have been satisfied; and

(g) Other factors, not enumerated, which would demonstrate the osteopathic physician’s ability to safely engage in the practice of osteopathic medicine.

Specific Authority 459.005, 459.015 FS. Law Implemented 456.072(6), 459.015 FS. History–New 10-13-03.

64B15-19.006 Supervision of Physician Assistant. No Physician whose license to practice medicine has been placed on probation shall, during the term of probation, serve as a Primary Supervising Physician or Alternate Supervising Physician, or in any other supervisory capacity, to a Physician Assistant.

Specific Authority 459.005, 459.022 FS. Law Implemented 459.015(2)(g), 459.022(2)(f) FS. History–New 4-18-89, Formerly 21R-19.006, 61F9-19.006, 59W-19.006.

64B15-19.007 Citations. (1) As used in this rule, “citation” means an instrument which meets the requirements set forth in Section 456.077, F.S., and

which is served upon a licensee or certificateholder for the purpose of assessing a penalty in an amount established by this rule. (2) In lieu of the disciplinary procedures contained in Section 456.073, F.S., the Department is hereby authorized to dispose of

any violation designated herein by issuing a citation to the subject for a complaint that is the basis for the citation. (3) The following violations with accompanying fines may be disposed of by citation. (a) Falsely certifying compliance with required continuing medical education hours for the purpose of renewing a license or

certificate. The fine shall be $2,000. (b) Failure to keep current practice address on file with the Board. The fine shall be $250. (c) Failure to register as a dispensing practitioner. The fine shall be $500. (d) First time failure of the licensee to satisfy continuing education hours. The fine shall be $150 for each hour not completed

or completed late. In addition, the licensee shall make up all hours not completed, and shall be required to take 1 additional hour of continuing education for each hour not completed or completed late. Respondent must submit certified documentation of completion of all CEU requirements for the period for which the citation was issued prior to renewing the license for the next biennium. Respondent must document compliance with the CEU requirements for the relevant period.

(e) Failure to report to the Board within 30 days after the licensee has been convicted or found guilty of, or entered a plea of nolo contendere to, regardless of adjudication, a crime in any jurisdiction. The fine shall be $800.

(f) Failure to conspicuously list the name of the osteopathic physician in an advertisement as required in paragraph 64B15-14.001(2)(k), F.A.C. The fine shall be $500.

(g) Advertising or holding oneself out as a board-certified specialist, if not qualified under Section 459.0152, F.S. The fine shall be $1,500.

(h) Failure to include the disclosure statement in an advertisement as required in Section 456.062, F.S. The fine shall be $750. (i) Failure to timely provide medical records of only one patient. The fine shall be $500. (j) Excessively charging copying fees for patient records as specified in Rule 64B15-15.003, F.A.C. The fine shall be $750. (k) Failure to update physician profile as required in Sections 456.039(3) and 459.008, F.S. The fine shall be $50 per day not in

compliance not to exceed $5,000. (l) Failure to comply with Section 381.0261, F.S., by failing to inform patients of the address and telephone number of the

agency responsible for responding to patient complaints or failure to make available a summary of rights to patients as required in Sections 459.015(1)(g) and 456.072(1)(k), F.S.; Section 381.0261(4)(b), F.S. The fine shall be $100 non-willful and $500 willful.

(m) Failure to report another licensee in violation; Sections 456.072(1)(i) and 459.015(1)(e), F.S. The fine shall be $500. (n) Allowing a physician in training who has failed to register as required in Section 459.021, F.S., to practice medicine. The

director of medical education in the training program shall be fined $500 for violating Section 456.072(1)(j), F.S. (o) Failure to comply with the guidelines for the use of obesity drugs in instances which do not result in patient harm. The fine

shall be $500. (4) If the subject does not dispute the matter in the citation in writing within 30 days after the citation is served by personal

service or within 30 days after receipt by certified mail, the citation shall become a final order of the Board of Osteopathic Medical Examiners. The subject has 30 days from the date the citation becomes a final order to pay the fine and costs. Failure to pay the fine and costs within the prescribed time period constitutes a violation of Section 459.015(1)(cc), F.S., which will result in further disciplinary action. All fines and costs are to be made payable to “Department of Health – Citation.”

(5) Prior to issuance of the citation, the investigator must confirm that the violation has been corrected or is in the process of being corrected.

(6) Once the citation becomes a final order, the citation and complaint become a public record pursuant to Chapter 119, F.S., unless otherwise exempt from the provisions of Chapter 119, F.S. The citation and complaint may be considered as aggravating circumstances in future disciplinary actions pursuant to Rule 64B15-19.003, F.A.C.

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(7) The procedures described herein apply only for an initial offense of the alleged violation. Subsequent violation(s) of the same rule or statute shall require the procedures of Section 456.073, F.S., to be followed. In addition, should an initial offense for which a citation could be issued occur in conjunction with violations not described herein, then the procedures of Section 455.225, F.S., shall apply.

Specific Authority 456.073, 456.077 FS. Law Implemented 456.073, 456.077 FS. History–New 10-28-91, Amended 8-24-92, 11-17-92, Formerly 21R-19.007, 61F9-19.007, 59W-19.007, Amended 11-27-97, 11-12-00, 1-29-03, 7-13-03, 5-12-05.

64B15-19.008 Mediation. (1) “Mediation” means a process whereby a mediator appointed by the Department acts to encourage and facilitate resolution

of a legally sufficient complaint. It is an informal and non-adversarial process with the objective of assisting the parties to reach a mutually acceptable agreement.

(2) The board finds that the following offenses may be mediated if the offense meets the criteria of Section 456.078, F.S.: (a) Section 459.015(1)(d), F.S., false advertising. (b) Section 459.015(1)(g), F.S., failure to perform a statutory or legal obligation, with regard to violation of medical director

clinic responsibilities. (c) Section 459.015(1)(pp), F.S., violating any provision of this chapter or Chapter 456, F.S., or any rules adopted pursuant

thereto, with regard to failure to release patient records to a patient or a patient’s legal representative. (d) Section 459.015(1)(r), F.S., improper advertising of pharmacy; promoting or advertising on any prescription form of a

community pharmacy unless the form shall also state “This prescription may be filled at any pharmacy of your choice.” (e) Section 459.015(1)(x), F.S., failure to practice medicine with that level of care, skill, and treatment which is recognized by

a reasonably prudent similar physician as being acceptable under similar conditions and circumstances, provided that it does not result in patient harm or the performance of any surgical procedure.


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CHAPTER 64B15-20 FINANCIAL RESPONSIBILITY

64B15-20.001 Applicability. (Repealed) 64B15-20.002 Definitions. 64B15-20.003 Procedures. 64B15-20.004 Exemptions for Persons Not Practicing in Florida; Change of Status.

64B15-20.002 Definitions. The term “patient contact hours,” as used in Section 459.0085(5)(f)2., F.S., means the number of hours during which the physician is available to see patients or is performing patient care activities, including, but not limited to, completing patient records and reviewing laboratory reports.


64B15-20.003 Procedures. (1)(a) At the time a person seeks initial licensure or reactivation of an inactive license that person or his employer must show

compliance with the requirements of Section 472.008, F.S., before a license, or an active license, respectively, shall be issued. (b) During the license renewal period of each biennium, an application for renewal will be mailed to each licensee at the last

address provided to the Board. Failure to receive any notification during this period does not relieve the licensee of the responsibility of meeting the financial responsibility or license renewal requirements.

(2)(a) The application for initial licensure, renewal, or reactivation shall include a form on which the licensee shall make a notarized written statement asserting that he or she is in compliance with the financial responsibility law and identifying the form of compliance (escrow account, insurance, or letter of credit) or asserting that he or she is exempt from the requirements of financial responsibility and identifying the claimed exemption (government employee, inactive licensee not practicing in Florida, holder of limited license, license or certificate holder practicing only in conjunction with teaching duties, active licensee not practicing in Florida, retiree or part-time practitioner, licensee who agrees to pay adverse judgment). The short-phrase terms used in the preceding sentence are only for purposes of identification; each licensee is responsible for reviewing the full and exact requirements for each method of compliance or delineation of exemption and for determining his compliance or eligibility based on the complete statutory language.

(b) The licensee must retain such written documentation as may be necessary to prove his or her compliance with or exemption from the financial responsibility requirements for a period of not less than 7 years and must provide such documentation to the Board or its agent upon request. The Board will audit at random a number of licensees as necessary to ensure that the financial responsibility requirements are met.

(3) Each licensee must notify the Board in writing of any change of status relating to financial responsibility compliance or exemption at least 10 calendar days prior to the change.

(4) The failure to document compliance with or exemption from the financial responsibility law upon request, the furnishing of false or misleading information, or the failure to timely notify the Board of a change in status shall be grounds for disciplinary action up and including license revocation.


64B15-20.004 Exemptions for Persons Not Practicing in Florida; Change of Status. (1)(a) Persons who are not practicing medicine in Florida may be exempt from compliance with the financial responsibility

requirements pursuant to Section 459.0085(5)(b), F.S. (licensees with inactive licenses) or Section 459.0085(5)(e), F.S. (licensees with active licenses), as follows:

(b) A licensee who has claimed an exemption based on the fact that the license is inactive and the licensee is not practicing medicine in Florida and who applies for reactivation of the medical license must, in addition to the other requirements for reactivation, either show that he or she maintained tail insurance for the time periods prescribed by the statute or submit an affidavit stating that he or she has no unsatisfied medical malpractice judgments or settlements at the time of application for reactivation;

(c) A licensee who has claimed an exemption based on the fact that, although an active license has been maintained, the licensee has not been practicing medicine in Florida must, before initiating or resuming the practice of medicine in this state, notify the Department of the intent to practice in the state and show compliance with the requirements of the financial responsibility law or show exemption therefrom in the manner set forth in Rule 64B15-20.003, F.A.C.;

(d) A licensee who is both reactivating an inactive license and initiating or resuming the practice of medicine in Florida must meet the requirements of both (a) and (b) above.


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CHAPTER 64B15-22 REGISTRATION OF HOSPITAL RESIDENTS AND INTERNS

64B15-22.001 Definitions.64B15-22.002 Duties of an Intern.64B15-22.003 Duties of a Resident Osteopathic Physician.64B15-22.004 Mandatory Registration of Unlicensed Physicians.

64B15-22.001 Definitions. (1) An unlicensed physician is a person holding a degree as a Doctor of Osteopathic Medicine from a college of osteopathic

medicine recognized and approved by the American Osteopathic Association but not licensed by the Board of Osteopathic Medicine. For the purpose of administering this rule chapter, such unlicensed physicians shall embrace and include interns, residents, and fellows as these terms are defined herein.

(2) An intern is a physician with an osteopathic medical degree or its equivalent who is continuing his training. This training ordinarily follows immediately upon the granting of the doctor of osteopathic medicine degree. The term “intern” also means a first year resident or post graduate year one physician.

(3) A resident osteopathic physician is one who has completed an internship and is engaged in a program of training designed to increase his knowledge of the clinical disciplines of medicine, surgery or any of the other special fields which provide advanced training in preparation for the practice of a specialty. In the years following the internship, the person is usually referred to as a resident physician.

(4) A fellow is an osteopathic physician who is engaged in a program of training leading to a subspeciality board certification or certificate of added qualification.

Specific Authority 459.005, 459.021(7) FS. Law Implemented 459.021 FS. History–New 10-28-91, Amended 1-3-93, Formerly 21R-22.001, 61F9-22.001, 59W-22.001, Amended 1-19-98.

64B15-22.002 Duties of an Intern. An internship consists of the supervised care of patients in a hospital and in its out-patient department, with continued instruction in the science and art of osteopathic medicine by the hospital staff. The physician-student is given the opportunity to put into practice the principles of preventive medicine, diagnosis, therapy, and patient management which he learned as a medical student. He is able to observe patients on an “around the clock” basis and can follow patients from admission to discharge and subsequently in the out-patient department. Under the supervision of the attending staff, he is given progressively increasing responsibility to the end that he acquires confidence in his own clinical judgment. For the training to be approved, the hospital where the internship is served must be approved by the American Osteopathic Association, or by the Board.


64B15-22.003 Duties of a Resident Osteopathic Physician. A resident physician participates in an organized post graduate educational program in which he has daily contact with patients and assumes increasing responsibility for their care under the supervision of the attending staff of the hospital. The assumption of responsibility is a most important aspect of residency training. As each resident physician demonstrates increasing knowledge and ability, an increasing amount of reliance should be placed in his judgment in the diagnosis and in treatment of patients. He may also participate in the teaching of interns and medical students to an increasing extent. In surgery and surgical specialties, the resident physician should be given ample opportunity to perform major surgical procedures under direct supervision of qualified members of the professional staff of the hospital, particularly in the later stages of his training, in order that he may acquire surgical skill and judgment.


64B15-22.004 Mandatory Registration of Unlicensed Physicians. Registration as a resident, intern, or fellow shall be accomplished by completing an application form supplied by the Department. Said application shall include the following information:

(1) Full name and address. (2) Date of Birth. (3) The name and address of their training hospital/program. (4) The date of commencement of their internship or residency. (5) The name of the institution and the date of receipt of their Doctor of Osteopathic medicine degree.

Specific Authority 459.005, 459.021 FS. Law Implemented 459.021 FS. History–New 10-28-91, Amended 1-3-93, Formerly 21R-22.004, 61F9-22.004, 59W-22.004, Amended 1-19-98.

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