Current through Register Vol. 47, No. 6, September 18, 2024
(1)
Application and licensing. An ambulatory surgical center shall
obtain a license from the department in accordance with Iowa Code section
135R.2.
a. An ambulatory surgical center
seeking licensure will make application on forms provided by the department or
through the department's online application system. Upon receipt of a completed
application, including completion of the building and plan review set forth in
paragraph 49.2(1)"b," and receipt of the $50 fee set forth in
Iowa Code section 135R.3(3), the
application will be considered.
b.
An ambulatory surgical center applicant shall submit architectural technical
documents, engineering documents, and plans and specifications to the
department's building and construction division in accordance with rule
661-300.4 (103A) that
demonstrate the applicant's compliance with the construction and physical
environment requirements of subrule 49.4(2). The submission may be completed by
an authorized agent of the applicant or the responsible design professional,
who shall certify that the building or building plans meet the construction and
physical environment standards within subrule 49.4(2) or that a waiver has been
granted by the department for any noncompliant standard. If the applicant was
operating prior to and continuously since July 1, 2023, the applicant is
permitted up to six months after submission of its license application to
submit plans demonstrating compliance with subrule 49.4(1) or obtaining waivers
for the construction and physical environment standards in accordance with
subrule 49.4(2).
(2)
Certificate of need. An ambulatory surgical center will be
granted an initial license and is not required to obtain a new certificate of
need solely because licensure is mandated by Iowa Code chapter 135R if the
ambulatory surgical center was operating prior to and continuously since July
1, 2023. If an ambulatory surgical center beginning or modifying its operations
on or after July 1, 2023, would be required to obtain a certificate of need
from the health facilities council pursuant to Iowa Code chapter 10A,
subchapter VII, part 2, it shall obtain a certificate of need from the health
facilities council prior to submitting its license application to the
department.
(3)
Renewal,
changes of ownership, and changes of information. A license issued
pursuant to this chapter expires one year after the date of issuance or as
indicated on the license.
a.
Renewal. To renew a license, a completed application form
shall be submitted to the department 30 days prior to license
expiration.
b.
Change of
ownership. To request a change of ownership, a completed application
form shall be submitted to the department for the new owner at least 30 days
prior to the proposed effective date of the change of ownership. A change of
ownership includes the purchase, transfer, assignment, or lease of the licensed
ambulatory surgical center and includes a change in the management company
responsible for the day-to-day operation of the ambulatory surgical center if
the management company is ultimately responsible for any enforcement action
taken by the department. For purposes of determining ownership and whether such
changes constitute a change of ownership, the department adopts the Centers for
Medicare and Medicaid Services (CMS) State Operations Manual sections 3210.1A
and 3210.1D (Rev. 1, 05-21-04).
c.
Change of information. The department should be notified of
any changes to an applicant's or licensee's application information within 30
days of the date the change occurs, including the cessation of
operation.
(4)
Public display. The license shall be displayed in a
conspicuous place in the ambulatory surgical center viewed by the
public.
