Current through Register Vol. 42, No. 11, August 30, 2024
(1) Legal Authority
for Adoption of Rules. Under and by virtue of authority vested in it by the
Legislature of Alabama (Code of Ala. 1975, §§
22-21-20,
et
seq.), the State Board of
Health does hereby adopt and promulgate the following rules governing
outpatient surgical treatment centers licensed to operate in the State of
Alabama.
(2) Definitions (a list of
selected terms often used in connection with these Rules):
(a) AAC Rule means Alabama Administrative
Code Rule.
(b) Administrator means
a natural person who is the governing authority of a health care facility or a
natural person who is designated by the governing authority of a health care
facility. Such person must have sufficient authority to interpret and implement
all policies of the owner or proprietor, and must be sufficiently qualified to
perform those tasks. Such person shall be the addressee of all correspondence
and inquiries from the State Board of Health.
(c) Advisory Board. See Section
22-21-27 of Appendix.
(d) Ambulatory Surgical Center means any
health care facility with the primary purpose of providing medically necessary
or elective surgical care. Excluded from this definition are the offices of
private physicians and dentists, including those organized as professional
corporations, professional associations, partnerships, or sole proprietorships.
Also excluded from this definition are health care facilities defined as
hospitals under section (i), below.
(e) "Specialized Ambulatory Surgical Center"
means an ambulatory surgical center that provides surgical services in an
exclusive specialty, such as orthopedics, pediatrics, gynecology and
obstetrics, ophthalmology, or other specialized practice.
(f) Health Care Facility means any structure,
building, office, or portion thereof where medical procedures are
performed.
(g) Board or State Board
of Health means the Alabama State Board of Health.
(h) Facilities for Surgical Treatment of
Patients Not Requiring Hospitalization as referred to in these rules means
"Ambulatory Surgical Centers."
(i)
Governing Authority means the owner or proprietor of health care facility, or
the body, such as a board of directors, which exercises control over a health
care facility on behalf of its owner or proprietor.
(j) Hospital means a health care facility
duly licensed by the State Board of Health under Chapter 420-5-7, Alabama
Administrative Code, to offer to the public not less than fifteen beds and
other facilities for use in diagnosis and treatment of persons in need of acute
care for illness, disease, injury, deformity, infirmity, abnormality or
pregnancy. A health care facility meets this definition only if the facility is
licensed to offer and actually does offer such care or service for not less
than twenty-four consecutive hours in any week to two or more individuals not
related by blood or marriage to the owner and/or administrator of the
facility.
(k) Medical Director
(Qualified) means the physician responsible for planning, organizing,
conducting, and directing the medical affairs of the ambulatory surgical
center. The Physician-Director must meet either of the following requirements
to be considered qualified:
1. Is Board
Eligible or Board Certified in surgery or anesthesia and has had at least 12
months of experience or training in the care of patients in a surgical
environment; or
2. During the 5
year period prior to the effective date of these rules, has served for at least
12 months as director of a surgical unit.
However, in those areas where a qualified medical Director is
not available to direct an ambulatory surgical center, another physician may
direct the facility, subject to the approval of the Alabama State Board of
Health.
(k)
Medical Staff means currently licensed physicians and dentists and podiatrists
who are privileged by agreement with licensee to attend patients within the
institution.
(l) Patient means a
person admitted to the ambulatory surgical center by and upon the
recommendation of a physician and who is to receive the medical care
recommended by the physician.
(m)
Pharmacy means a place licensed by the Alabama State Board of Pharmacy in which
prescriptions, drugs, medicines, chemicals, and poisons are sold, offered for
sale, compounded or dispensed, and shall include all places whose title may
imply the sale, offering for sale, compounding or dispensing of prescriptions,
drugs, medicines, chemicals, or poisons.
(n) Pharmacist means a person currently
licensed to practice pharmacy in Alabama under the provisions contained in
current state statutes.
(o)
Physician means a person currently licensed by the Medical Licensure
Commission, State of Alabama, to practice medicine and surgery.
(p) Podiatrist means a person currently
licensed to practice podiatry in Alabama under the provisions of current state
statutes.
(q) Registered Nurse (RN)
means a professional registered nurse currently licensed in the State of
Alabama in accordance with the provisions contained in current state
statutes.
(r) Licensed Practical
Nurse (LPN) means a person currently licensed in the State of Alabama in
accordance with Code of Ala. 1975, §§
34-21-1,
et
seq.
(s) These Rules means Rules 420-5-2-01
through 420-5-2-.04, Chapter 420-5-2,
Ambulatory Surgical Treatment Facilities, Alabama Administrative
Code.
(3) Type of
License.
(a) Regular License. A regular
license may be issued by the State Board of Health after the Board has
determined that the outpatient surgical treatment center is in substantial
compliance with the rules herein adopted.
(b) Temporary License.
1. At its discretion, the State Board of
Health may issue a license which indicates a temporary condition of
non-compliance with these rules. A temporary license may be issued when the
Board is satisfied that preparations are being made to qualify for a regular
license or as provided below, and that notwithstanding the deficiencies,
appropriate measures have been taken to minimize any threat to the health and
safety of patients and personnel. A temporary license may be granted for a
calendar year, but not to exceed five (5) successive one-year terms.
2. An ambulatory surgical center may be
issued a temporary license prior to opening if in compliance with the
provisions of these rules relative to the physical plant and staffing. The
license issued under AAC Rule
420-5-2-.01(3)(b)
shall be valid until the issuance of a
regular license or December 31 of the year in which the license was issued
unless suspended or revoked prior to that date. A temporary license may be
reissued under AAC Rule
420-5-2-.01(3)(b)
when it has been demonstrated to the Board
that specific efforts are being made to comply with these rules.
3. An ambulatory surgical center which is in
existence on the effective date of these rules may be issued a temporary
license under one or more of the following conditions:
(i) Where failure to qualify for a regular
license is due to the requirements as herein required.
(ii) Where the governing authority is making
specific plans to establish an ambulatory surgical center which meets the rules
or is actually in the process of meeting these rules.
(iii) Where a formal appeal of an
administrative decision is pending action by the State Board of
Health.
(c)
Probational License. At its discretion, the State Board of Health may issue a
probational license under one or more of the following conditions, and then
only when the Board is satisfied, notwithstanding its deficiencies, appropriate
measures have been taken to minimize any threat to the health and safety of
patients and personnel. A probational license may be granted for a calendar
year not to exceed two successive one-year terms:
1. When the Board has reason to believe the
operation is questionable.
2. When
the Board has reason to believe the facility is not making specific plans to
comply with these rules or the ambulatory surgical center's ability to comply
is questionable.
3. Conduct or
practices not deemed by the Board to be in the patients' best interest, e.g.,
the owner(s), physicians, or employee(s) are determined to be unethical, have
committed fraud or abuse, or have been found to be aiding or abetting the
commission of an illegal act.
(4) Licensing.
(a) Application for License. All ambulatory
surgical centers shall apply for licensure on a form designated by the State
Board of Health. The application will reflect all data required by
Code of Ala. 1975, §§
22-21-20,
et
seq., a copy of which is
contained in Appendix.
(b) Fee. See
Section 22-21-24 of Appendix.
(c) Name of Facility. Every ambulatory
surgical center shall be designated by a permanent and distinctive name which
shall not be changed until an application has been completed and approved.
Words in the name of the center that may reflect a different type of facility
or service shall not be used.
(d)
Separate License. When more than one facility is operated under the same
operating entity, a separate license shall be required for each facility.
Separate licenses are not required for separate buildings on the same ground
used by the same facility.
(e)
Reissuance of License.
1. The following
changes in the status of the facility will require issuance of a new license,
upon application and payment of licensure fee (if applicable) as required by
current statutes:
(i) Change in facility
ownership or operating entity (fee required).
(ii) Change in name (no fee
required).
(iii) Change of locality
(no fee required).
2.
The governing authority shall file with the State Board of Health, an
application for license 30 days before any proposed change requiring a new
license, in order to permit processing of the application and issuance of the
license on the desired effective date of the change.
(f) Specialized Ambulatory Surgical Center.
Ambulatory surgical centers that limit their practice to a particular medical
specialty may apply for licensure as a specialized ambulatory surgical center.
A specialized ambulatory surgical center shall have a medical staff and other
professional and technical personnel qualified to provide surgical treatment
and services in the specialty area. A facility licensed as a specialized
ambulatory surgical center must limit its surgical practice to its designated
medical specialty. A specialized ambulatory surgical center is required to meet
all other requirements of these rules for ambulatory surgical
centers.
(5) Right of
Appeal.
(a) Review of Licensure Inspection
Reports and Statement of Deficiencies. In cases of errors or differences of
opinions as to interpretations and/or applicability of these rules, the
licensee may request orally or in writing a review of such points of
difference. Opportunity for prompt review shall be afforded by the Alabama
Department of Public Health and, where applicable, letters of clarification
sent to the licensee.
(b)
Administrative Decisions.
1. The Licensure
Advisory Board will provide an opportunity for a fair hearing to every licensee
who is dissatisfied with administrative decisions made in the application of
these rules.
2. The licensee shall
present his complaint in writing, within 30 days, and may, at his discretion,
be present during the hearing, and/or be represented by legal
counsel.
3. The licensee may
present such evidence as may be deemed necessary and pertinent to his
request.
4. Upon completion of the
hearing, the Licensure Advisory Board shall present its findings, conclusions,
and recommendations to the State Board of Health for final action.
(c) Decisions Made by State Board
of Health. Decisions rendered by the State Board of Health in respect to
licensure status or amendments to these rules shall be final and
binding.
(6) Exceptions.
(a) Research Projects Application for Waiver.
Any licensee who is or contemplates being engaged in a bona fide research
program which may be in conflict with one or more specific provisions of these
rules may make application for waiver of the specific provisions in conflict.
Application for waiver shall be made in writing to the Licensure Advisory Board
who shall, upon completion of its investigation, send its findings, conclusions
and recommendations to the State Board of Health for final action.
(b) Exceptions to Regulations. At its
discretion, the State Board of Health may grant an exception to, or modify the
application of, one or more provisions of these rules or reference codes for a
period and under conditions, if any, determined by the Board. The exceptions or
modifications shall be based on hardship, impracticality, or economic
infeasibility in complying with the rules. The center's request shall be in
writing, shall state the specific provisions for which the exception or
modification is requested, and reason for each requested exception or
modification.
(c) Disclosure of
Information. Information received through on-site inspections may be disclosed
to any interested party upon written request. Information received through
means other than inspections shall not be publicly disclosed.
L. O'Neal Green