The proposed substantial rewording of the rule is intended to address the newly enacted Section 458.328, F.S., regarding office surgery registration and the requirements for a designated physician.

 

DEPARTMENT OF HEALTH

Board of Medicine

RULE NO.:RULE TITLE:

64B8-9.0091Requirement for Physician Office Registration; Inspection or Accreditation

PURPOSE AND EFFECT: The proposed substantial rewording of the rule is intended to address the newly enacted Section 458.328, F.S., regarding office surgery registration and the requirements for a designated physician.

SUMMARY: The proposed substantial rewording of the rule addresses the newly enacted Section 458.328, F.S., regarding office surgery registration and the requirements for a designated physician.

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), 458.328(2) FS.

LAW IMPLEMENTED: 456.069, 458.328 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: Claudia Kemp, J.D., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(A SUBSTANTIAL REWORDING OF RULE 64B8-9.0091, F.A.C. SEE FLORIDA ADMINISTRATIVE CODE FOR PRESENT TEXT).

64B8-9.0091 Requirement for Physician Office Surgery Registration; Inspection or Accreditation.

(1) Registration.

(a) Office Registration. An office in which a physician performs liposuction procedures where more than 1,000 cubic centimeters of supernatant fat is removed, a Level II office surgery, or a Level III office surgery shall register with the Department of Health (Department) unless the office is licensed as facility under Chapter 390 or Chapter 395, Florida Statutes. The office must notify the Department within 10 calendar days after the termination of a designated physician relationship and must notify the Department of the designation of another physician to serve as the designated physician.

(b) Designated Physician. Each office registered in Subparagraph (1)(a) must designate a physician who is responsible for office’s compliance with the health and safety requirements of Section 458.328, F.S., Rule 64B8-9,009, F.A.C., and this rule, including any changes to the office registration in paragraph (1)(a) above. The designated physician is required to update within 10 days any modifications to the office surgery registration application regarding the recovery personnel and persons on the surgical team along with supporting documentation if said person is not a physician.

(c) Physician Registration. Each physician practicing at a registered office shall notify the Board in writing within 10 calendar days after beginning or ending his or her practice at a registered office. The physician must comply with the requirements and qualifications of Section 458.328, F.S., Rule 64B8-9.009, F.A.C., and this rule.  The written notification for beginning office surgery practice requires the physician to provide and document the following information:

1. Financial Responsibility. All physicians practicing at a registered office must meet the financial responsibility requirements of Section 458.320/459.0085, F.S., as applicable, and notify the Board of the option he or she elects.

2. For surgeons:

a. the level of surgery the physician intends to perform;

b. the types of procedures the physician intends to perform at this registered office;

c. whether the physician holds current certification of eligibility with a specialty board approved by the Florida Board of Medicine and if so, to submit a copy of the certificate or board-eligibility letter with the notification;

d. if the physician does not hold current certification or board eligibility, the physician must provide documentation to establish comparable background, training, and experience;

e. if the physician intends to perform procedures not covered by the registered office’s transfer agreement, submission of a letter of good standing and a copy of the delineation of staff privileges as set forth in Rules 64B8-9.009 (4)(b) 1, F.A.C.;

f.  submit a copy of the physician’s current Advanced Cardiac Life Support (ACLS) certification; and

g. list the dates of attendance and specialty areas of all residency, fellowship, background experience, and additional training.

3.  For physicians who are anesthesia providers, submission of a current copy of the ACLS card or Pediatric Advanced Life Support (PALS) card (if appropriate), and

4.  For assistants to the surgeon, submission of a current copy of the Basic Life Support (BLS) card.

(d) In order to register at an office for office surgery, the physician must comply with the Department’s Rule 64B-4.003, F.A.C., and provide documentation to support compliance with Rule 64B8-9.009, F.A.C., and this rule.

(e) The registration shall be posted in the office.

(2) Inspection.

(a) Unless the office has previously provided written notification of current accreditation by a nationally recognized accrediting agency or an accrediting organization approved by the Board, the office  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) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). 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 office surgery inspection fee set forth in the Department’s Rule 64B-4.002, F.A.C., shall be remitted for each practice location.

(c) For those inspections which are required to be announced, such inspections shall be announced at least one week in advance of the arrival of the inspector(s).

(d) If the office is determined to be in noncompliance, the designated physician shall be notified and shall be given a written  statement specifying the deficiencies at the time of inspection. If the designated physician is not present at the time of the inspection, the written statement shall be provided to the designated physician’s designee and a copy shall be provided to the designated physician. Unless the deficiencies constitute an immediate and imminent danger to the public, the designated 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 designated physician that all deficiencies have been corrected, the Department is authorized to re-inspect for compliance. If the designated physician fails to submit a corrective action plan within 30 days of the inspection, the Department is authorized to re-inspect the office to ensure that the deficiencies have been corrected.

(e) The deficiency notice and any subsequent documentation shall be reviewed for consideration of disciplinary action under any of the following circumstances:

1. When the initial notice of deficiencies contain deficiencies that constitute immediate and imminent danger to the public;

2. The designated physician fails to provide the Department with documentation of correction of all deficiencies within thirty (30) days from the date of inspection; or

3. Upon a finding of noncompliance after a reinspection has been conducted pursuant to paragraph (2)(d), of this rule.

(f) Documentation of corrective action shall be considered in mitigation of any offense.

(g) Nothing herein shall limit the authority of the Department to investigate a complaint without prior notice.

(3) Accreditation.

(a) The office shall submit written notification of the current accreditation survey 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 office  shall submit, within thirty (30) days of accreditation, a copy of the current accreditation survey of its office and shall immediately notify the Department of any accreditation changes that occur. For purposes of initial registration, an office shall submit a copy of its most recent accreditation survey in lieu of undergoing an inspection by the Department.

(c) If a provisional or conditional accreditation is received, the office shall notify the Department in writing and shall include a plan of correction.

Rulemaking Authority 458.309(1), (3) 458.328(2) FS. Law Implemented 456.069, 458.328, 458.309(3) FS. History–New 5-15-00, Amended 9-18-01, 8-5-03, 9-1-03, 2-9-05, 8-22-06, 10-30-07, 1-9-13, 3-3-13, 12-22-14,                           .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Joint Committee on Surgical Care

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

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: December 6, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: December 31, 2019