To provide for physician, nurse midwives, and licensed midwives reporting of adverse incidents associated with planned out-of-hospital births as defined in section 456.0495, F.S., pursuant to recently enacted legislation.

 

DEPARTMENT OF HEALTH

RULE NO.: RULE TITLE:

64-5.001: Out of Hospital Birth Adverse Incident Reporting

PURPOSE AND EFFECT: To provide for physician, nurse midwives, and licensed midwives reporting of adverse incidents associated with planned out-of-hospital births as defined in section 456.0495, F.S., pursuant to recently enacted legislation.

SUMMARY: This rulemaking provides a form and process for physicians, nurse midwives and licensed midwives to report adverse incidents associated with planned out-of-hospital births.

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: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

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: 456.0495, FS.

LAW IMPLEMENTED: 456.0495, 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: Lucy Gee, Division Director, 4052 Bald Cypress Way, Bin #C-00, Tallahassee, Florida 32399 or Lucy.Gee@@FlHealth.gov.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64-5.001 Out-of-Hospital Birth Adverse Incident Reporting.

A physician licensed under chapter 458 or 459, a nurse midwife certified under part I of chapter 464, or a midwife licensed under chapter 467, shall report adverse incidents, as defined in section 456.0495, F.S., over which he or she could exercise control that are associated with a planned out-of-hospital birth to the Department on Form DH5029-MQA, Adverse Incident Report for Planned Out-of-Hospital Births, 07/2018, incorporated by reference and available at https://www.flrules.org/Gateway/reference.asp?No=Ref-####, within 15 days after the adverse incident occurs.

 

Rulemaking Authority 456.0495, FS. Law Implemented 456.0495, FS. History–New,                 .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Lucy Gee, Division Director, Division of Medical Quality Assurance

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: September 25, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: June 7, 2018