The proposed rule amendments are intended to incorporate the office adverse incident reporting form into the rule and to delete unnecessary language from the rule.  

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    DEPARTMENT OF HEALTH

    Board of Medicine

    RULE NO.:RULE TITLE:

    64B8-9.001Physician Office Incident Reporting

    PURPOSE AND EFFECT: The proposed rule amendments are intended to incorporate the office adverse incident reporting form into the rule and to delete unnecessary language from the rule.

    SUMMARY: The proposed rule amendments delete outdated and unnecessary language from the rule.

    SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

    The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.             

    The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: During discussion of the economic impact of this rule at its Board meeting, the Board concluded that this rule change will not have any impact on licensees and their businesses or the businesses that employ them. The rule will not increase any fees, business costs, personnel costs, will not decrease profit opportunities, and will not require any specialized knowledge to comply. This change will not increase any direct or indirect regulatory costs. Hence, the Board determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. No person or interested party submitted additional information regarding the economic impact at that time.

    Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

    RULEMAKING AUTHORITY: 458.309(1), 458.351(6) FS.

    LAW IMPLEMENTED: 458.351 FS.

    IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

    THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: André Ourso, J.D., M.P.H., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253.

     

    THE FULL TEXT OF THE PROPOSED RULE IS:

     

    64B8-9.001 Physician Office Adverse Incident Reporting.

    (1) Any "adverse incident" as defined in Section 458.351(4), F.S., shall be reported to the Department of Health in accordance with Section 458.351, F.S., on form DH-MQA1030 12/06, entitled "Physician Office Adverse Incident Report," which is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-__________.

    (2)(1) Definitions.

    (a) “Adverse incident” for purposes of reporting to the department, is defined in Section 458.351, F.S., as an event over which the 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 a physician for the practice of medicine which is not licensed under Chapter 395, F.S.

    (a)(b) “Licensee” for purposes of this rule, includes a physician or physician assistant issued a license, registration, or certificate, for any period of time, pursuant to Chapter 458, F.S.

    (b)(c) “Office maintained by a physician” as that term is used in Section 458.351(1), F.S., is defined as a business location where the 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 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, 4052 Bald Cypress Way, Bin #C75, Tallahassee, Florida 32399. The report shall be made on the Physician Office Adverse Incident Report. 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 subparagraph 3.

    5. The name, license number, locating information, and signature of the physician or licensee submitting the report, along with date and time that the report was completed.

    (3)(b) Adverse Incident Report Review and Analysis. Evidence of compliance with this paragraph will be considered in mitigation in the event the Board takes disciplinary action.

    (a)1. The physician shall be responsible for the regular and systematic reviewing of all incident reports filed by the physician or physician assistant under the 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 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.

    (b)2. Copies of incident reports shall be maintained in the physician office.

    (3) Death Reports. Notwithstanding the provisions of this rule and Section 458.351, F.S., an adverse incident which results in death shall be reported immediately to the medical examiner pursuant to Section 406.12, F.S.

    Rulemaking Specific Authority 458.309(1), 458.351(6) FS. Law Implemented 458.351 FS. History–New 3-9-00, Amended_________.

     

    NAME OF PERSON ORIGINATING PROPOSED RULE: Rules Committee, Board of Medicine

    NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Medicine

    DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 7, 2015

    DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: August 28, 2015

Document Information

Comments Open:
9/15/2015
Summary:
The proposed rule amendments delete outdated and unnecessary language from the rule.
Purpose:
The proposed rule amendments are intended to incorporate the office adverse incident reporting form into the rule and to delete unnecessary language from the rule.
Rulemaking Authority:
458.309(1), 458.351(6) FS.
Law:
458.351 FS.
Contact:
André Ourso, J.D., M.P.H., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.
Related Rules: (1)
64B8-9.001. Physician Office Incident Reporting