Fla. Admin. Code Ann. R. 64B8-9.0091 - Requirement for Physician Office Surgery Registration; Inspection or Accreditation
Current through Reg. 47, No. 249; December 28, 2021
(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, F.S. 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 paragraph (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 Sections
458.320
and
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 does not hold current
certification or board eligibility or provide documentation to establish
comparable background, training, and experience, submission of a letter of good
standing and a copy of the delineation of staff privileges as set forth in
subparagraph
64B8-9.009(4)(b)
2., F.A.C.;
f. If the physician
does not provide a letter of good standing and a copy of the delineation of
staff privileges as set forth in subparagraph
64B8-9.009(4)(b)
2., F.A.C., the physician must provide a copy of a current transfer agreement
with a licensed hospital within 30 minutes transport time from the surgery
facility as set forth in subparagraph
64B8-9.009(4)(b)
1., F.A.C.
g. Submit a copy of the
physician's current Advanced Cardiac Life Support (ACLS) certification;
and
h. 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.
Notes
Rulemaking Authority 458.309(1), 458.328 (2) FS. Law Implemented 456.069, 458.328 FS.
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