AUTHORITY: Implementing and authorized by the Ambulatory Surgical Treatment Center Act [210 ILCS 5].
SOURCE: Amended July 18, 1974; emergency amendment at 3 Ill. Reg. 10, p. 43, effective February 23, 1979, for a maximum of 150 days; amended at 3 Ill. Reg. 30, p. 371, effective July 23, 1979; amended at 5 Ill. Reg. 12756, effective November 4, 1981; amended at 6 Ill. Reg. 6220, 6225, and 6226, effective May 17, 1982; amended at 6 Ill. Reg. 10974, effective August 30, 1982; amended at 6 Ill. Reg. 13337, effective October 20, 1982; amended at 7 Ill. Reg. 7640, effective June 14, 1983; codified at 8 Ill. Reg. 9367; amended at 9 Ill. Reg. 12014, effective July 23, 1985; amended at 10 Ill. Reg. 8806, effective June 1, 1986; amended at 10 Ill. Reg. 21906, effective January 15, 1987; amended at 11 Ill. Reg. 14786, effective October 1, 1987; amended at 12 Ill. Reg. 3743, effective February 15, 1988; amended at 12 Ill. Reg. 15573, effective October 1, 1988; amended at 13 Ill. Reg. 16025, effective November 1, 1989; emergency amendment at 14 Ill. Reg. 5596, effective March 26, 1990, for a maximum of 150 days; amended at 14 Ill. Reg. 13802, effective August 15, 1990; amended at 15 Ill. Reg. 17770, effective December 1, 1991; amended at 17 Ill. Reg. 3507, effective March 3, 1993; amended at 18 Ill. Reg. 11939, effective July 22, 1994; amended at 18 Ill. Reg. 17250, effective December 1, 1994; amended at 22 Ill. Reg. 9335, effective May 20, 1998; amended at 22 Ill. Reg. 22019, effective December 4, 1998; amended at 24 Ill. Reg. 2691, effective February 18, 2000; amended at 25 Ill. Reg. 7471, effective May 31, 2001; amended at 26 Ill. Reg. 16556, effective October 25, 2002; amended at 27 Ill. Reg. 13457, effective July 25, 2003; amended at 31 Ill. Reg. 7278, effective May 7, 2007; amended at 32 Ill. Reg. 14326, effective August 12, 2008; amended at 33 Ill. Reg. 13395, effective September 10, 2009; amended at 34 Ill. Reg. 7915, effective May 25, 2010; amended at 38 Ill. Reg. 19208, effective September 9, 2014; expedited correction at 39 Ill. Reg. 5519, effective September 9, 2014; amended at 40 Ill. Reg. 13933, effective September 21, 2016; amended at 44 Ill. Reg. 18358, effective November 2, 2020; amended at 46 Ill. Reg. 14215, effective July 28, 2022; amended at 48 Ill. Reg. 13763, effective August 28, 2024; amended at 48 Ill. Reg. 15862, effective October 24, 2024; Subchapter b recodified at 48 Ill. Reg. 17400.
SUBPART A: GENERAL PROVISIONS
Section 205.110 Definitions
"Act" means the Ambulatory Surgical Treatment Center Act.
"Ambulatory Surgical Center" shall have the meaning ascribed to it in 42 CFR 416.
"Ambulatory Surgical Treatment Center"
The term "Ambulatory Surgical Treatment Center" or "ASTC" or "facility", for the purposes of this Part, includes:
Any institution or building devoted primarily to the maintenance and operation of facilities for the performance of surgical procedures, and any place that meets and complies with the definition of an ambulatory surgical treatment center under the Act and this Part, as evidenced by use of the facilities by physicians, podiatrists or dentists in the performance of surgical procedures that constitutes more than 50 percent of the activities at that location.
Any place, located within an institution or building, such as a surgical suite or an operating room with related facilities in a physician's office or group practice clinic, devoted primarily to the performance of surgical procedures. This provision shall apply regardless of whether or not the institution or building in which the place is located is devoted primarily to the maintenance and operation of facilities for the performance of surgical procedures. This provision shall include any place that meets the definition of an ambulatory surgical center under the rules of the federal Centers for Medicare & Medicaid Services. However, when a place is located within, and operated in conjunction with, the offices of a single physician, podiatrist, or dentist, or a group of physicians, podiatrists, or dentists, it shall not be considered an ambulatory surgical treatment center unless: it meets the definition of and has expressed an intent to apply for certification as an ambulatory surgical center under the rules of the federal Centers for Medicare & Medicaid Services; or it is used by physicians, podiatrists, or dentists who are not part of the practice; or it is utilized by the physicians or podiatrists for surgical procedures that constitute more than 50 percent of the activities at that location.
The term "Ambulatory Surgical Treatment Center", for the purposes of this Part, does not include:
Hospitals: Any institution, place, building or agency required to be licensed pursuant to the Hospital Licensing Act.
Long-Term Care Facilities: Any person or institution required to be licensed pursuant to the Nursing Home Care Act, the Specialized Mental Health Rehabilitation Act of 2013, the ID/DD Community Care Act, or the MC/DD Act.
State Facilities: Hospitals or ambulatory surgical treatment centers maintained by the State or any Department or agency thereof, where such department or agency has authority under law to establish and enforce standards for the hospitals or ambulatory surgical treatment centers under its management and control.
Federal Facilities: Hospitals or ambulatory surgical treatment centers maintained by the federal government or agencies thereof.
Dental Surgery Facilities: Any place, agency, clinic, or practice, public or private, whether organized for profit or not, devoted exclusively to the performance of dental or oral surgical procedures.
Other Facilities: Any facility in which the performance of abortion procedures, including procedures to terminate a pregnancy or to manage pregnancy loss, is limited to those performed without general, epidural, or spinal anesthesia, and which is not otherwise required to be an ambulatory surgical treatment center. For purposes of this definition, "general, epidural, or spinal anesthesia" does not include local anesthesia or intravenous sedation. Nothing in the Act and this Part shall be construed to limit a facility of this type from voluntarily electing to apply for licensure as an ambulatory surgical treatment center. (Section 3(A) of the Act)
"Certified Registered Nurse Anesthetist" means a registered professional nurse who has been certified as a nurse anesthetist by the American Association of Nurse Anesthetists.
"Credentials Committee" means the qualified consulting committee, or another committee designated by the qualified consulting committee, that appraises and reviews physician credentials.
"Department" means the Department of Public Health of the State of Illinois. (Section 3(C) of the Act)
"Hospital" shall have the meaning ascribed to it in the Hospital Licensing Act.
"Licensed Practical Nurse" means a person licensed under the Nurse Practice Act to practice practical nursing.
"Overnight Stay" means the expected duration of services exceeds 24 hours following an admission.
"Qualified Anesthesiologist" means a physician who is licensed to practice medicine in all its branches in the State of Illinois and who is a Diplomate of the American Board of Anesthesiology; or who is a Diplomate of the American Osteopathic Board of Anesthesiology; or who is Board eligible or possesses training and experience equivalent to that eligibility; or who possesses training and experience acceptable to the Department and whose primary practice is anesthesiology.
"Qualified Consulting Committee" means a committee whose members are qualified surgeons, obstetricians, gynecologists, anesthesiologists or pathologists or other consulting physicians consisting of not fewer than three members who shall establish the required standards commensurate with the size, scope, extent and complexity of service programs and procedures for which the facility is licensed. The qualified consulting committee or other committee designated by the qualified consulting committee shall act as the credentials committee.
"Qualified Consulting Surgeon, Obstetrician, Gynecologist, Anesthesiologist, Pathologist, or other Consulting Physician" means a physician who is licensed in the State of Illinois and who is a Diplomate of an appropriate specialty board or who has completed the training and experience required for specialty board certification.
"Qualified Dentist" means a dentist who is licensed to practice under the Illinois Dental Practice Act.
"Qualified Infection Control Professional" means an individual who either has training, education and experience or has certification in the principles and methods of infection control. The individual shall maintain his or her qualifications through ongoing education and training.
"Qualified Physician" means an individual who is licensed to practice medicine in all its branches in the State of Illinois under the Medical Practice Act of 1987.
"Qualified Podiatrist" means a podiatrist who is licensed to practice under the Podiatric Medical Practice Act of 1987.
"Qualified Practitioner" means a licensed practitioner who is authorized within his or her scope of practice to perform a history and physical examination and who is authorized by the ASTC to conduct a history and physical examination. This may include nurse practitioners and physician assistants.
"Registered Professional Nurse" or "RN" means a registered professional nurse who is licensed under the Nurse Practice Act and practices professional nursing.
"Student Nurse" means a person enrolled in a course of instruction at an approved school of professional or practical nursing and who is supervised by a nursing instructor of the school.
"Surgical smoke plume" means the by-product of the use of energy-based devices on tissue during surgery and containing hazardous materials, including, but not limited to, bioaerosols, smoke, gases, tissue and cellular fragments and particulates, and viruses. (Section 6.9(a) of the Act)
"Surgical smoke plume evacuation system" means a dedicated device that is designed to capture, transport, and filter surgical smoke plume at the site of origin and before it can diffuse and pose a risk to the occupants of the operating or treatment room. (Section 6.9(a) of the Act)
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)
Section 205.115 Incorporated and Referenced Materials
a) The following regulations and standards are incorporated in this Part:
1) Private and Professional Association Standards:
A) American Society of Testing and Materials (ASTM), E 84 (2010), Standard Test Method for Surface Burning Characteristics of Building Materials, which may be obtained from the American Society for Testing and Materials, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959
B) The following standard of the National Fire Protection Association (NFPA), which may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02169: NFPA 101 (2012), Life Safety Code and all applicable references under Chapter 2, Referenced Publications.
C) The following standards of the American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE), which may be obtained from the American Society of Heating, Refrigerating, and Air Conditioning Engineers, Inc., 180 Technology Parkway NW, Peachtree, GA 30092:
i) Standard 52.2: Method of Testing General Ventilation Air Cleaning Devices for Removal Efficiency by Particle Size (2017) (see Section 205.1540(i)).
ii) Standard 55: Thermal Environmental Conditions for Human Occupancy and Addendum (2023) (see Section 205.1540(i)).
iii) Standard 58: Method of Testing for Rating Room Air Conditioner and Packaged Terminal Air Conditioner Heating Capacity (2014) (see Section 205.1540(i)).
iv) Standard 62.1: Ventilation and Acceptable Indoor Air Quality (2022) (see Section 205.1540(i)).
v) Standard 63.1: Method of Testing Liquid Line Refrigerant Driers (1995) (see Section 205.1540(i)).
vi) Standard 63.2: Method of Testing Liquid-Line Filter Drier Filtration Capacity (2017) (see Section 205.1540(i)).
vii) Standard 64: Methods of Testing Remote Mechanical-Draft Evaporative Refrigerant Condensers (2020) (see Section 205.1540(i)).
viii) Standard 68: Laboratory Method of Testing to Determine the Sound Power in a Duct (1997) (see Section 205.1540(i)).
ix) ASHRAE Handbook of Fundamentals (2009) (see Section 205.1540(p)).
D) Underwriters Laboratories, Inc. (UL), Publication No. 181 (2013): Factory-Made Air Ducts and Air Connectors, which may be obtained from Underwriters Laboratories, Inc., 333 Pfingsten Road, Northbrook, IL 60062. (See Section 205.1710.)
E) American College of Cardiology/Society for Cardiac Angiography and Interventions, Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards, published in the Journal of the American College of Cardiology, September, 2012; 37:2170-2214, which may be obtained from the American College of Cardiology, Heart House, 2400 N. St. NW, Washington, DC 20037, or by calling 202-375-6000, or toll free at 800-253-4636.
F) Association of periOperative Registered Nurses, Guidelines for Perioperative Practice (2024), available at: https://www.aorn.org/guidelines-resources/guidelines-for-perioperative-practice or from the Association of periOperative Registered Nurses, 2170 South Parker Road, Suite 400, Denver, CO 80231.
2) Federal Regulations:
A) Rules of the Centers for Medicare & Medicaid Services governing Medicare program coverage of Ambulatory Surgical Services (42 CFR 416, October 1, 2023) under the Social Security Act (42 U.S.C. 1395). (See definition of "Ambulatory Surgical Treatment Center" in Section 205.110 and Section 205.130(d).)
B) Rules of the Centers for Medicare & Medicaid Services governing federal certification of laboratory requirements (42 CFR 493, October 1, 2023). (See Section 205.350, Laboratory Services.)
3) Federal Government Publications:
A) Department of Health and Human Services, United States Public Health Service, Centers for Disease Control and Prevention, "2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" (July 2023), available at: https://www.cdc.gov/infection-control/media/pdfs/guideline-isolation-h.pdf?CDC_AAref_Val=https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines-H.pdf National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161.
B) Department of Health and Human Services, United States Public Health Service, Centers for Disease Control and Prevention, "Guideline for Hand Hygiene in Health-Care Settings", October 25, 2002, available at: https://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf or from the National Technical Information Service (NTIS), U.S. Department of Commerce, 5285 Port Royal Road, Springfield, VA 22161.
C) Department of Health and Human Services, United States Public Health Service, Centers for Disease Control and Prevention, "Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008" (May 2019), available at: https://www.cdc.gov/infection-control/media/pdfs/guideline-disinfection-h.pdf?CDC_AAref_Val=https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines-H.pdf the Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333.
D) Department of Health and Human Services, United State Public Health Service, Centers for Disease Control and Prevention, "Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care", September 2016, available at: https://www.cdc.gov/infection-control/media/pdfs/outpatient-guide-508.pdf?CDC_AAref_Val=https://www.cdc.gov/infectioncontrol/pdf/outpatient/guide.pdf or from the Centers for Disease Control and Prevention, 1600 Clifton Road, Atlanta, GA 30333.
b) All incorporations by reference of federal regulations and guidelines and the standards of nationally recognized organizations refer to the regulations, guidelines and standards on the dates specified and do not include any amendments or editions subsequent to the date specified.
c) The following statutes and State administrative rules are referenced in this Part:
1) State of Illinois Statutes:
A) Ambulatory Surgical Treatment Center Act [210 ILCS 5]
B) Illinois Dental Practice Act [225 ILCS 25]
C) Nurse Practice Act [225 ILCS 65]
D) Podiatric Medical Practice Act of 1987 [225 ILCS 100]
E) Safety Glazing Materials Act [430 ILCS 60]
F) Hospital Licensing Act [210 ILCS 85]
G) Nursing Home Care Act [210 ILCS 45]
H) Illinois Health Facilities Planning Act [20 ILCS 3960]
I) Illinois Administrative Procedure Act [5 ILCS 100]
J) Laser System Act of 1997 [420 ILCS 56]
K) Illinois Clinical Laboratory and Blood Bank Act [210 ILCS 25]
L) Physician Assistant Practice Act of 1987 [225 ILCS 95]
M) Administrative Review Law [735 ILCS 5/Art. III]
N) Specialized Mental Health Rehabilitation Act of 2013 [210 ILCS 49]
O) ID/DD Community Care Act [210 ILCS 47]
P) MC/DD Act [210 ILCS 46]
Q) Pharmacy Practice Act [225 ILCS 85]
R) Latex Glove Ban Act [410 ILCS 180]
2) State of Illinois Administrative Rules:
A) Department of Public Health, Illinois Plumbing Code (77 Ill. Adm. Code 890)
B) Illinois Emergency Management Agency, General Provisions for Radiation Protection (32 Ill. Adm. Code 310)
C) Department of Public Health, Control of Sexually Transmissible Infections Code (77 Ill. Adm. Code 693)
D) Department of Public Health, Control of Notifiable Diseases and Conditions Code (77 Ill. Adm. Code 690)
E) Department of Public Health, Control of Tuberculosis Code (77 Ill. Adm. Code 696)
F) Pollution Control Board, Standards for Owners and Operators of Hazardous Waste Treatment, Storage, and Disposal Facilities (35 Ill. Adm. Code 724)
G) Pollution Control Board, Special Waste Hauling (35 Ill. Adm. Code 809)
H) Department of Public Health, Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100)
I) Capital Development Board, Illinois Accessibility Code (71 Ill. Adm. Code 400)
J) Illinois Emergency Management Agency, Standards for Protection Against Radiation (32 Ill. Adm. Code 340)
K) Illinois Emergency Management Agency, Use of X-rays in the Healing Arts Including Medical, Dental, Podiatry, and Veterinary Medicine (32 Ill. Adm. Code 360)
L) Department of Public Health, Health Care Professional Credentials Data Collection Code (77 Ill. Adm. Code 965)
M) Department of Public Health, Pregnancy Termination Report Code (77 Ill. Adm. Code 505)
(Source: Amended at 48 Ill. Reg. 15862, effective October 24, 2024)
Section 205.118 Conditions of Licensure
a) No person shall open, conduct or maintain an ambulatory surgical treatment center without first obtaining a license from the Department. (Section 4 of the Act)
1) A person or facility not licensed under the Act or the Hospital Licensing Act shall not hold itself out to the public as a "surgery center" or as a "center for surgery". (Section 6 of the Act)
2) Any person opening, conducting or maintaining an ambulatory surgical treatment center without a license issued pursuant to the Act shall be guilty of a business offense punishable by a fine of $10,000 and each day's violation shall constitute a separate offense.
3) Any person opening, conducting or maintaining an ambulatory surgical treatment center who violates any other provision of the Act shall be guilty of a business offense punishable by a fine of not more than $10,000. (Section 12 of the Act)
4) The operation or maintenance of an ambulatory surgical treatment center in violation of the Act or this Part is declared a public nuisance inimical to the public welfare. The Director of the Department, in the name of the People of the State, through the Attorney General or the State's Attorney of the county in which the violation occurs, may, in addition to other remedies provided in the Act, bring action for an injunction to restrain such violation or to enjoin the future operation or maintenance of any such ambulatory surgical treatment center. (Section 13 of the Act)
b) The applicant shall file a statement of ownership as provided in Section 205.120(b)(1). The applicant shall agree to update the information required in the statement of ownership every six months from the initial date of filing. (Section 7a of the Act)
c) Every facility licensed under the Act, and any premises proposed to be conducted as a facility by an applicant for a license, shall be open during its regular business hours to an inspection authorized in writing by the Director. No notice need be given to any person prior to any inspection. (Section 9 of the Act)
d) Any corporation operating an ambulatory surgical treatment center devoted primarily to providing facilities for abortion must have a physician who is licensed to practice medicine in all of its branches and is actively engaged in the practice of medicine at the ambulatory surgical treatment center, on the Board of Directors as a condition to licensure of the ambulatory surgical treatment center. (Section 6.1 of the Act)
e) Each license shall be issued only for the premises and persons named in the application and shall not be transferable or assignable (Section 6 of the Act). Only those facilities, services, programs and procedures included in the application shall be licensed. A new application is required for any one or more of the following:
1) Change in ownership of the facility. A change of ownership occurs when:
A) Ownership and responsibility for the operation of the assets constituting the licensed entity are transferred from the licensee to another person or another legal entity, including, but not limited to, a corporation, limited liability company, partnership or sole proprietor, as part of an asset purchase or similar transaction;
B) In a partnership, when the removal, addition or substitution of a partner alters control of the partnership by more than 51%; or
C) In a corporation, when the licensee corporation merges into another corporation or is party to a consolidation transaction with one or more corporations, resulting in the creation of a new corporation.
2) Change in location of the facility.
3) Any remodeling or other change in the facility's physical plant that increases or decreases the number of rooms in which surgical procedures are performed.
f) The transactions described in subsection (e)(1) do not constitute a change in ownership when all of the entities that are parties to the transaction are under common control or ownership before and after the transaction is completed. In these transactions, the name of the corporation, its officers, its independent subsidiaries and any other relevant information that the Department may require shall be made available to the Department upon request.
g) The transfer of corporate stock, the change of a membership interest, or the merger of another corporation into the licensee corporation does not constitute a change of ownership if the licensee corporation remains in existence.
h) The license shall be valid for one year, unless sooner suspended or revoked, and shall be renewable annually upon approval by the Department and payment of a license fee of $300 as provided in Section 205.125. (Section 6 of the Act)
i) The license shall be posted in a conspicuous place on the licensed premises. A placard or registry of all physicians on staff in the facility shall be centrally located and available for inspection to any interested persons. (Section 6 of the Act)
j) The facility shall give written notice to the Department no later than seven days after any one or more of the following:
1) Any personnel changes involving the facility's administrative staff, medical director or supervising nurse.
2) For a corporation, any change in any shareholders equity involving 5% or more interest.
3) Any change in the Registered Agent or person or persons legally authorized to receive service of process for the facility.
k) An ambulatory surgical treatment center that elects to have an agreement with the federal Centers for Medicare and Medicaid Services, as provided in 42 CFR 416, must also meet the Medicare conditions as an ambulatory surgical center, as set forth in 42 CFR 416, and have an active agreement with the federal Centers for Medicare and Medicaid Services to participate in Medicare as an ambulatory surgical center provider in Illinois. (Section 6.8 of the Act)
(Source: Amended at 40 Ill. Reg. 13933, effective September 21, 2016)
Section 205.120 Application for Initial Licensure
a) An application for license shall be made to the Department on forms provided by the Department (Section 5 of the Act). The application shall be submitted not less than sixty days prior to the date of intended operation and shall contain the information required under the Act and this Part.
b) The initial application shall include the following information:
1) The names and addresses of all persons who own the facility, any names under which any of these persons do business, and the type of ownership of the facility (for example, individual, partnership, corporation, or association). In addition, a corporation shall submit:
A) A copy of its certificate of incorporation,
B) A list of the title, name, and address of each of its corporate officers,
C) A list of the name and address of each of its shareholders holding more than five percent of the shares.
2) For other than individual ownership, the name and address of the Illinois Registered Agent or person(s) legally authorized to receive service of process for the facility.
3) The names and addresses of all persons under contract to manage or operate the facility.
4) The location of the facility.
5) Information regarding any conviction of the applicant, or if the applicant is a firm, partnership or association, of any of its members, or if the applicant is a corporation, of any of its officers or directors, or of the person designated to manage or supervise the facility, of a felony, or of two or more misdemeanors involving moral turpitude in the last five years.
6) The name, address, telephone number, education, experience, credentials and any professional licensure or certification of the following persons:
A) Administrator.
B) Medical Director.
C) Supervising Nurse.
7) A list of the medical staff including name, specialty and license number.
8) A list of all staff personnel including name, position, education, experience, and any professional licensure or certification.
9) A narrative description of the facility including but not limited to interviewing, examination, surgical and recovery room facilities.
10) A description of services to be provided by the facility including a list of surgical procedures to be performed and documentation of the Consulting Committee's approval of the list.
11) Documentation of compliance with Section 205.350 of this Part.
12) A copy of the transfer agreement with a licensed hospital within approximately 15 minutes travel time of the facility or other documentation demonstrating compliance with Section 205.540(d) of this Part.
13) A copy of the organizational plan of the facility (see Section 205.220).
14) Schematic architectural plans.
15) Documentation of a permit as required by the Illinois Health Facilities Planning Act (Ill. Rev. Stat. 1991, ch. 111½, par. 1151 et seq.) [20 ILCS 3960].
16) Documentation of compliance with all applicable local building, utility, and safety codes.
c) The application shall be signed by the applicant and shall include a verification form acknowledging the application to be true and complete and certifying that the applicant has knowledge of and understands the action required to comply with the Act and licensing requirements. The form shall be verified by a notary public. (Section 5 of the Act)
d) The license application shall be accompanied by a license fee of $500. (Section 5 of the Act)
(Source: Amended at 18 Ill. Reg. 17250, effective December 1, 1994)
Section 205.125 Application for License Renewal
a) Application for license renewal shall be submitted on forms provided by the Department. Application for license renewal shall be submitted to the Department not less than 30 days prior to the expiration date.
b) An application for license renewal shall include the following information:
1) The names and addresses of all persons who own the facility, any names under which any of these persons do business, and the type of ownership of the facility (for example, individual, partnership, corporation, or association). In addition, a corporation shall submit:
A) A list of the title, name and address of each of its corporate officers.
B) A list of the name and address of each of its shareholders holding more than 5% of the shares.
2) For other than individual ownership, the name and address of the Illinois Registered Agent or person(s) legally authorized to receive service of process for the facility.
3) The names and addresses of all persons under contract to manage or operate the facility.
4) The location of the facility.
5) Information regarding any conviction of the applicant, or if the applicant is a firm, partnership or association, of any of its members, or if the applicant is a corporation, of any of its officers or directors, or of the person designated to manage or supervise the facility, of a felony, or of two or more misdemeanors involving moral turpitude during the previous year.
6) The name, address, and telephone number of the administrator, medical director, and supervising nurse. In addition, the education, experience, credentials and any professional licensure or certification of these individuals must also be submitted if this information was not submitted with the initial application or a prior renewal application or if this information has changed since the prior submission.
7) A list of the medical staff including name, specialty and license number.
8) A list of all staff personnel including name, position, education, experience, and any professional licensure or certification.
9) A list of surgical procedures being performed at the facility and documentation of the Consulting Committee's approval of the list.
c) The application shall be signed by the applicant and shall include a verification form acknowledging the application to be true and complete and certifying that the applicant has knowledge of and understands the action required to comply with the Act and licensing requirements. The form shall be verified by a notary public. (Section 5 of the Act)
d) The license renewal application shall be accompanied by a license renewal fee of $300. (Section 6 of the Act)
(Source: Amended at 18 Ill. Reg. 17250, effective December 1, 1994)
Section 205.130 Approval of Surgical Procedures
a) The list of surgical procedures performed by a center shall be included in the application as provided in Section 205.120 and in the renewal application as provided in Section 205.125. All surgical procedures to be performed in a facility must be approved by the facility's Consulting Committee prior to their performance, and annually reviewed and reapproved. Documentation of the approval must be submitted with the initial and renewal applications.
b) If, after reviewing the quarterly data submission required by Section 205.620 of this Part, the Department questions the safety of a procedure being performed because of the complications or postoperative hospitalizations reported as being associated with the procedure, the Department shall request that the facility's Consulting Committee review the reported cases and submit the findings of that review within 30 days after the request.
c) The Department may disapprove a procedure based upon the following:
1) The Department's review of the statistical information submitted in accordance with Section 205.620 of this Part and the Consulting Committee's review required in subsection (b) above indicate that the procedure cannot be safely performed in the surgery center as indicated by life threatening or repeated complications, or repeated postoperative hospitalizations; or
2) The results of a complaint investigation indicate that the procedure is potentially life threatening or results in repeated complications or postoperative hospitalizations; or
3) Evidence becomes available from other sources, such as a national study or a warning from the Food and Drug Administration or other regulatory body, that the procedure cannot be safely performed in an ambulatory setting.
d) The Director shall issue a Notice of Disapproval, which shall be effective immediately, and which shall provide the facility with fifteen days in which to request a hearing to contest the Notice of Disapproval. Such hearing will be conducted by the Department in accordance with the Department's administrative hearing rules (77 Ill. Adm. Code 100) and the Illinois Administrative Procedure Act (Ill. Rev. Stat. 1991, ch. 127, par. 1001-1 et seq.) [5 ILCS 100].
(Source: Amended at 18 Ill. Reg. 17250, effective December 1, 1994)
Section 205.135 Diagnostic Cardiac Catheterization Procedures
Diagnostic cardiac catheterization procedures may be performed in an ambulatory surgical treatment center in accordance with the following requirements:
a) The procedure shall be approved by the facility's consulting committee in accordance with Section 205.130 of this Part.
b) The procedure shall meet the general exclusion criteria for invasive cardiac procedures in settings without cardiac surgery in Table 2 of the Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards (see Section 205.115(a)(1)(E)).
c) The facility shall meet Criteria C: Cardiac Catheterization and Diagnostic Procedures in the Freestanding Laboratory and Criteria D: Candidates for Same-Day or Ambulatory Cardiac Catheterization of the Clinical Expert Consensus Document on Cardiac Catheterization Laboratory Standards.
(Source: Added at 26 Ill. Reg. 16556, effective October 25, 2002)
SUBPART B: OWNERSHIP AND MANAGEMENT
Section 205.210 Ownership, Control and Management
a) The ASTC shall have a governing body that assumes full responsibility for determining, implementing and monitoring policies governing the facility's operation:
1) The governing body shall review and approve the facility's organizational plan.
2) The governing body shall ensure that ASTC policies and programs provide quality health care in a safe environment.
3) The governing body shall have oversight and accountability for the facility's Quality Assessment and Performance Improvement Program; shall allocate sufficient resources for the Program; and shall, at least annually, evaluate the Program's effectiveness.
4) The governing body shall approve an infection control program designed to prevent, identify and manage infections and communicable diseases. The governing body shall appoint a qualified infection control professional who will direct the infection control program. The governing body shall, at least annually, evaluate the effectiveness of the infection control program.
5) The governing body shall establish, protect and promote patient rights, including respect for patients' property and privacy, patient safety, the confidentiality of clinical records, and the exercise of patient rights. The governing body shall designate a grievance officer and shall establish, subject to approval by the governing body, a documented system by which allegations will be reported, investigated and responded to. Allegations will include allegations of violations/grievances relating to, but not limited to, mistreatment, neglect, or verbal, mental, sexual or physical abuse.
6) The governing body shall have oversight and accountability for developing and maintaining a written Disaster Preparedness Plan pursuant to Section 205.510 and shall review reports and recommendations at least annually.
7) The governing body shall review and approve the facility's organizational plan (see Section 205.220).
b) Ownership, control and management shall be disclosed at the time of application and upon renewal. The names and addresses of each person with financial interest in the facility shall be submitted to the Department.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
Section 205.220 Organizational Plan
a) An organizational plan shall be known to the staff and available for public information in the facility. The document shall clearly set forth the organization, duties, responsibility, accountability and relationships of professional staff, including a designated qualified infection control professional, a designated grievance officer, and other personnel.
b) The plan shall include details of a quality assessment and performance improvement program, an infection control program, a patient rights plan, and a disaster preparedness plan.
c) The organizational plan shall be submitted to the governing body for review and approval and shall be submitted to the Department with the initial licensure application.
d) All owners, administrators, professional staff and ancillary personnel shall act in accordance with the organizational plan.
e) The Department will review the organizational plan at regular inspections.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
Section 205.230 Standards of Professional Work
The owner or manager of the ambulatory surgical treatment center shall maintain proper standards of professional work in the facility.
a) A qualified consulting committee shall be appointed in writing by the management or owner of the ambulatory surgical treatment center and shall establish and enforce standards for professional work in the facility and standards of competency for physicians. The qualified consulting committee shall meet not less than quarterly and shall document all meetings with written minutes. The minutes shall be maintained at the facility and shall be available for Department inspection.
1) The membership of the qualified consulting committee shall reflect the types of procedures performed. If the facility performs more than 50 procedures per month, or more than 10% of the total procedures performed are in a specific specialty area, then a consulting physician of that specialty shall be on the qualified consulting committee.
2) The qualified consulting committee shall review the development and content of the facility's written policies and procedures, including the details of the quality assessment and performance improvement program, the infection control program, the patient rights plan, the disaster preparedness plan, the procedures for granting privileges, and the quality of the surgical procedures performed. The reviews shall be documented in the minutes.
3) The qualified consulting committee shall establish the scope of procedures to be performed at the facility and shall periodically review and amend the scope of procedures as appropriate.
4) Physicians seeking practice privileges at the facility shall provide their credentials. The credentials committee shall periodically reappraise and review physician credentials and shall identify and record specific practice privileges pursuant to the Health Care Professional Credentials Data Collection Code. A record of accepted practice privileges shall be available for facility staff use and for public information within the facility.
5) Each member of the medical staff granted specific surgical practice privileges shall provide, at every re-credentialing period, a notarized statement or documentation indicating the name of the Illinois licensed hospital or hospitals where he or she has skilled-equivalent practice privileges. The statements or documentation shall be available for Department inspection. A list of privileges granted to each medical staff member of the ambulatory surgical treatment center shall be available at all times for facility staff use and for Department inspection. As used in this subsection (a)(5), "skilled-equivalent" means the ability to perform similar procedures requiring the same level of training and expertise.
6) The qualified consulting committee shall act as a tissue committee and shall review, at least quarterly, pathological reports from procedures performed by each physician on the staff, when applicable. The review shall be documented in the minutes.
7) A dentist may be privileged at an ambulatory surgical treatment center if it is determined that the patient under the care of the dentist requires sedation beyond the training that the dentist possesses. The determination of need for sedation shall be made by the medical director of the facility where the procedure is to be performed. A dentist performing a surgical procedure requiring sedation at a facility must either:
A) Have admitting privileges at a nearby hospital where patients would receive care in the event of an emergency arising during a dental surgical procedure; or
B) Have a memorandum of understanding with a physician who has admitting privileges at such a hospital. (Section 6(3)(b) of the Act)
b) A qualified physician shall be designated as the medical director.
1) The medical director shall secure compliance with the policies and procedures pertaining to medical and surgical procedures, approved by the qualified consulting committee.
2) The medical director shall implement medical policies and procedures contained in the facility's policies and procedures manual (Section 205.240) governing the professional personnel involved directly in the care of patients undergoing surgical procedures, including their preoperative and postoperative care and follow-up.
3) The medical director shall establish and secure compliance with standards for patient observation by nursing personnel during the postoperative period.
(Source: Amended at 44 Ill. Reg. 18358, effective November 2, 2020)
Section 205.240 Policies and Procedures Manual
a) In cooperation with the medical and professional staff, the management/owner of the ambulatory surgical treatment center shall formulate a written policies and procedures manual, which shall be submitted to the qualified consulting committee and the governing body for review and approval.
b) The procedures shall provide for the acceptance, care, treatment, anesthesia services, discharge, referral, and follow-up of all patients and all incidental operations of the facility.
c) The policies and procedures manual shall include an ongoing data-driven quality assessment and improvement program that addresses measurable improvements in patient health outcomes and improves patient safety by addressing quality of care indicators or performance measures, adverse events, the reduction of medical errors, and infection control. Components of the quality assessment and improvement program shall include:
1) The use of quality indicators or performance measures and data to document improvements in outcomes and to effect improvements in patient care, patient health outcomes, and patient safety;
2) Measurement, identification and analysis of incidence, prevalence, severity and causes of the problems and tracking and implementing improvements that are sustained over time to reduce medical errors and to improve health outcomes;
3) The facility-wide infection control program (Section 205.550); and
4) A focus on performance improvement activities and preventive strategies that address high risk, high volume, and problem-prone areas that affect health outcomes, patient safety, and quality of care, and that address adverse patient events and ensure that improvements are sustained over time.
d) Data, activities and outcomes of quality assessment and improvement efforts and projects are to be reviewed at least annually and submitted annually in writing to the governing body.
e) The policies and procedures manual shall include a methodology for conducting an ongoing comprehensive assessment of the quality of care provided in the facility, including the medical necessity of procedures performed, the appropriateness of care, and methods to revise and implement changes in existing policies and procedures.
f) The policies and procedures manual shall include an ongoing infection control program designed to prevent, investigate, manage, control and minimize infections and communicable diseases.
g) The policies and procedures manual shall include a written disaster preparedness plan that provides for the emergency care of patients, staff and others in the facility in the event of a fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of patients and staff in the facility. The plan's effectiveness shall be tested and evaluated each year by conducting and evaluating drills, and by promptly implementing any needed corrections. The plan shall be coordinated with State and local authorities, as appropriate.
h) The policies and procedures manual shall include a written patient rights plan that includes the designation of a grievance officer, a system to protect and promote patient rights, and a system to investigate violations or incidents and grievances.
i) The policies and procedures manual shall be available to all staff in the facility and shall be followed by the staff at all times in the performance of their duties.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
SUBPART C: PERSONNEL
Section 205.310 Personnel Policies
a) Each ambulatory surgical treatment center shall have written personnel policies including job descriptions for each staff position, which shall include minimum qualifications required for the position. There shall be a documented procedure for orientation of new employees to the facility's policies and procedures as well as the personnel policies including a copy of the appropriate job description.
b) Prior to employing any individual in a position that requires a State license, the ambulatory surgical treatment center shall contact the Illinois Department of Professional Regulation to verify that the individual's license is active. A copy of the license shall be placed in the individual's personnel file.
c) The ambulatory surgical treatment center shall check the status of all applicants with the Nurse Aide Registry prior to hiring.
(Source: Amended at 27 Ill. Reg. 13457, effective July 25, 2003)
Section 205.320 Presence of Qualified Physician
a) A qualified physician shall be present at the facility until all patients are medically discharged, unless the facility possesses a written transfer agreement with a hospital and a qualified physician certifies that all remaining patients in the facility meet the criteria in this Section at the time the last remaining qualified physician departs the facility. The following criteria shall be met if a qualified physician will not be physically present at a facility:
1) The patient is awake, physiologically stable, has experienced no intraoperative or postoperative complications;
2) The patient does not require the administration of whole blood or any blood products;
3) The patient is three years of age or older;
4) The patient does not have an active, acute or chronic infectious condition;
5) The patient falls within anesthesia class I, II or III, if he or she is medically stable (anesthesia class I indicates a normal, healthy patient, anesthesia class II is a patient with mild systemic disease, and anesthesia class III is a patient with severe systemic disease);
6) The level of care needed by the patient is consistent with recovery care for generally healthy patients undergoing surgical procedures that require nursing care, pain control or observation;
7) Hospitalization is not required; and
8) The facility has met all other level of care criteria established by the qualified consulting committee.
b) The facility shall provide a sufficient number of properly trained and supervised staff to meet the needs of each patient. When a qualified physician is not on-site, the facility shall have at least two RNs on duty and present at the facility when patients are in a facility. All nursing staff providing care to patients shall meet the following criteria:
1) Be certified for advanced cardiac life support (ACLS) and, if applicable, pediatric advanced cardiac life support (PALS); and
2) Have a minimum of two years of experience within the last five years in a post-anesthesia recovery unit or medical/surgical unit of an acute care hospital or ambulatory surgical treatment center.
c) A qualified physician shall be on-call and able to be physically present in the facility within 15 minutes after a request from an on-duty RN.
d) Patients shall be discharged only after a written signed order by a member of the medical staff.
e) The discharge criteria shall be defined in writing by the qualified consulting committee.
(Source: Amended at 44 Ill. Reg. 18358, effective November 2, 2020)
Section 205.330 Nursing Personnel
a) At least one registered professional nurse with postgraduate education or experience in surgical nursing shall direct and supervise the nursing personnel and the nursing care of patients and shall be on duty at all times on the premises when patients are present.
b) Nursing care may be provided by student nurses and licensed practical nurses who have been trained in observation and emergency techniques for preoperative and postoperative care of surgical patients and who are under the direct personal supervision of a registered nurse at all times.
(Source: Amended at 12 Ill. Reg. 3743, effective February 15, 1988)
Section 205.340 Basic Life Support
At least one person who is certified in "Basic Life Support" by the American Heart Association shall be on the premises while patients are present.
(Source: Amended at 3 Ill. Reg. 30, p. 371, effective July 23, 1979)
Section 205.350 Laboratory Services
Each ambulatory surgical treatment center shall:
a) Possess a valid Clinical Laboratory Improvement Amendments (CLIA) certificate or waiver for those tests performed by the facility (42 CFR 493; Regulations Implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)).
b) Have a written agreement with a laboratory that possesses a valid CLIA certificate or waiver to perform any required laboratory procedures that are not performed in the ASTC.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
SUBPART D: EQUIPMENT, SUPPLIES, AND FACILITY MAINTENANCE
Section 205.410 Equipment and Related Policies
Equipment shall be in good working order and shall be available in numbers sufficient to provide quality patient care based on the types of procedures to be performed in the facility.
a) Monitoring equipment, suction apparatus, oxygen and related items shall be available within the surgical and postoperative recovery areas. Cardiac and pulmonary resuscitation equipment shall be available in all facilities.
b) The facility shall have written policies and procedures and shall maintain documentation governing the care, use, decontamination, sterilization, storage and disposal of all materials to ensure that an adequate supply of sterile equipment, instruments and supplies is available for each procedure. Written policies and procedures shall include documentation that the facility has considered, selected and implemented nationally recognized guidelines, including the Centers for Disease Control and Prevention publication, "Guidelines for Disinfection and Sterilization in Healthcare Facilities" or "Guide to Infection Prevention in Outpatient Settings"; or the Association of periOperative Registered Nurses (AORN) publication "Guidelines for Perioperative Practice". The policies, procedures and documentation shall include and address:
1) Staff orientation and in-service training to understand and implement facility policies and procedures for infection control, and to adhere to manufacturer's instructions for receiving, decontaminating, cleaning, preparing, sterilizing and high-level disinfection, handling, storage and quality control of equipment, supplies and instruments;
2) Preventive maintenance of all central supply service equipment pursuant to manufacturer's instructions or infection control guidelines; and
3) The Infection Control Program (Section 205.550), which shall be under the direction of a designated qualified health care professional with training in infection control.
c) The facility shall have written procedures to assure safety in the storage and use of inhalation anesthetics and medical gases in accordance with NFPA 99.
d) The facility shall have written procedures to assure the safety in storage and use of all narcotics and medications in accordance with State and federal law.
e) Facilities using laser equipment shall maintain documentation that the equipment is registered with the Illinois Emergency Management Agency as is required by the Laser System Act of 1997. The facility shall also have a written safety and maintenance program related to the use of the laser equipment.
f) The use of latex gloves by facility staff is prohibited. If a crisis exists that interrupts a facility's ability to reliably source nonlatex gloves, facility staff may use latex gloves upon a patient. However, during the crisis, facility staff shall prioritize, to the extent feasible, using nonlatex gloves for the treatment of any patient with self-identified allergy to latex; and any patient upon whom the latex gloves are to be used who is unconscious or otherwise physically unable to communicate and whose medical history lacks sufficient information to indicate whether or not the patient has a latex allergy. (Sections 10(c) and 15 of the Latex Glove Ban Act)
g) To protect patients, staff, and occupants in the operating or treatment room from the hazards of surgical smoke plume, the facility shall adopt policies to ensure the elimination of surgical smoke plume by use of a surgical smoke plume evacuation system for each procedure that generates surgical smoke plume from the use of energy-based devices, including, but not limited to electrosurgery and lasers. (Section 6.9(b) of the Act)
1) The facility's surgical department shall perform a risk assessment to identify all procedures that are performed with energy-based surgical devices (e.g. lasers, electrosurgical instruments, and ultrasonic devices) that generate a surgical smoke plume and will require the use of a surgical smoke plume evacuation system.
2) All surgical team members shall be trained on the methods for mitigating the hazards and minimizing exposure to surgical smoke plume, positioning and operating surgical smoke plume evacuation pursuant to the manufacturer's instructions, and the requirements in facility policies and procedures for management of surgical smoke plume.
3) Staff shall wear appropriate respiratory protection when needed as secondary protection against residual surgical smoke in accordance with the hospital's respiratory protection plan.
4) To protect against potential smoke hazards, the facility's policy and procedure shall, at a minimum, include:
A) During utilization of the smoke evacuator, the suction nozzle inlet shall be positioned as close to the surgical site as possible to maximize capture of airborne contaminants.
B) The smoke evacuator shall be turned on (activated) at all times when airborne particles are produced during all surgical or other procedures.
C) New tubing shall be used before each procedure and the smoke evacuator filter shall be replaced as recommended by the manufacturer. Consider all tubing, filters, and absorbers as infectious waste and dispose of appropriately.
D) The facility shall perform regular inspection, including inspection immediately prior to use, of surgical smoke evacuator systems to ensure proper functioning.
5) The facility shall report to the Department that policies under subsection (g) have been adopted. (Section 6.9(c) of the Act) The facility shall provide the Department a letter identifying the date of the adoption of the facility's policy for the utilization of surgical smoke evacuation systems.
(Source: Amended at 48 Ill. Reg. 15862, effective October 24, 2024)
Section 205.420 Sanitary Facility
a) The ambulatory surgical treatment center shall ensure maintenance of a safe and sanitary facility by developing and adhering to an infection control program that is based on nationally recognized infection control guidelines, including the Centers for Disease Control and Prevention publication "Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" or "Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care", and by maintaining all equipment in good working order. Written procedures shall include provision for maintaining a clean and sanitary facility, including appropriate environmental cleaning, garbage and refuse removal, insect and rodent control, maintenance of water, heat, ventilation and air conditioning, and electrical service.
b) Any blood, blood components, organs, semen, or other human tissue showing exposure to human immunodeficiency virus (HIV) as evidenced by two reactive ELISA test results (according to the package insert – product circular), or exposure to any other identified causative agent of Acquired Immunodeficiency Syndrome (AIDS), and any blood, blood components, organs, semen, or other human tissue originating from a patient diagnosed with HIV infection or AIDS as defined in 77 Ill. Adm. Code 693.20, shall be disposed of by the facility in accordance with subsection (c), or delivered in accordance with subsection (d) to a research facility for HIV or AIDS research.
c) Any blood, blood components, organs, semen or other human tissue, and any other materials or paraphernalia exposed to, or contaminated by, the blood, blood components, organs, semen or other human tissue shall be completely incinerated, sterilized or sealed to render the materials innocuous before disposal or removal from the premises.
1) Materials shall be incinerated in accordance with the requirements of the Pollution Control Board concerning the operation of an incinerator.
2) Materials shall be sterilized by autoclaving in accordance with the recommendations of the manufacturer of the autoclave. The effectiveness of the autoclave shall be verified and documented at least weekly with a biological spore assay containing B. stearothermophilus.
3) Incinerated or sterilized materials shall be disposed of through routine waste disposal methods.
4) Materials that have not been incinerated or sterilized shall be disposed of by a waste hauler with a permit from the Illinois Environmental Protection Agency under rules of the Pollution Control Board. These materials shall be sealed, transported and stored in biohazard containers. The containers shall be marked "Biohazard", bear the universal biohazard symbol, and be orange, orange and black, or red. The containers shall be rigid and puncture resistant, such as a secondary metal or plastic can with a lid that can be opened by a step-on pedal. The containers shall be lined with one or two high density polyethylene or polypropylene plastic bags with a total thickness of at least 2.5 mil. or equivalent material. The containers shall be sealed before being removed from the facility.
d) When a facility delivers blood, blood components, organs, semen or other human tissue to a research facility, the ASTC shall file a report with the Department (Division of Laboratories) that shall include at least the following information:
1) A copy of the request from the research facility for the blood, blood components, organs, semen or other human tissue;
2) The quantity of blood, blood components, organs, semen or other human tissue delivered;
3) The name and location of the research facility to which the blood or other human tissue was delivered; and
4) The date and time of delivery.
e) A research facility, for the purposes of this Section, shall mean any clinical laboratory or blood bank licensed under the Illinois Clinical Laboratory and Blood Bank Act, or any hospital licensed under the Hospital Licensing Act.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
SUBPART E: GENERAL PATIENT CARE
Section 205.510 Disaster Preparedness
a) Each facility shall develop and maintain a disaster preparedness plan that includes patients, staff and others in the facility. The plan shall cover fire, natural disasters, functional failure of equipment, explosion, and non-patient medical emergencies or other unexpected events or circumstances. The plan shall be tested bi-annually for effectiveness with drills and written evaluations. Any corrections to the plan shall be promptly implemented. This plan shall specify persons to be notified and actions to be taken and shall be known by all staff of the facility.
b) Each facility shall be prepared to manage those medical emergencies that may be associated with procedures performed there.
c) For the purposes of this Section, "emergency" means a situation, physical condition or one or more practices, methods or operations that present imminent danger of death or serious physical or mental harm to patients of an ASTC.
(Source: Amended at 46 Ill. Reg. 14215, effective July 28, 2022)
Section 205.520 Preoperative Care
a) The ASTC shall develop and maintain a policy that:
1) Identifies patients who require a medical history and physical examination prior to surgery and the timeframe in which the examination is to be completed prior to the surgery;
2) Considers the type of surgical procedure, age of the patient, and planned levels of anesthesia;
3) Addresses common diagnoses and known comorbidities; and
4) Is based on applicable nationally recognized standards of practice.
b) If the ASTC determines that a medical history and physical examination is required based on the policy requirements in subsection (a), it shall be obtained within the timeframe specified in the policy and included in the patient's medical record before beginning the surgical procedure.
c) If a patient is referred from a private physician's office, hospital, or clinic, the ASTC may accept a medical history and physical examination from the referring entity. The medical history and physical examination shall be included in the patient's clinical record at the time of the patient's registration and admission to the ASTC.
d) Upon admission, each patient shall have a pre-surgical assessment completed by a physician or other qualified practitioner that shall include documentation of any allergies to drugs or biologicals.
e) For procedures requiring a medical history and physical examination based on the policy requirements in subsection (a), changes in the patient's condition since completion of the most recently documented medical history and physical examination shall be documented.
f) A preanesthetic evaluation shall be completed specifically identifying any patient sensitivity or contraindications to anesthesia.
g) The laboratory examinations required on all admissions shall be determined by the qualified consulting committee and shall be consistent with the scope and nature of the ambulatory surgical treatment center. The required list or lists of tests shall be in written form and shall be available to all members of the medical staff.
h) Prior to procedures performed to terminate pregnancy, the physician shall establish the diagnosis of pregnancy by appropriate clinical evaluation and testing. In addition, the patient's blood Rh factor shall be determined.
i) A written statement indicating informed consent and a signed authorization by the patient for the performance of the specific surgical procedure shall be procured and made part of the patient's clinical record.
j) Surgical procedures shall not be performed on patients having medical, surgical or psychiatric conditions or complications as specified by the qualified consulting committee in the ASTC's written policies.
k) Prior to admission to the facility for a surgical procedure, the patient shall be informed of the following:
1) Patients who receive general anesthesia, intravenous sedation, spinal or epidural anesthesia, or any other specific anesthesia technique designated by the qualified consulting committee shall not attempt to drive a motor vehicle immediately upon discharge from the facility.
2) Patients shall arrange prior to admission for safe transportation upon discharge from the facility.
(Source: Amended at 46 Ill. Reg. 14215, effective July 28, 2022)
Section 205.530 Operative Care
a) Surgical procedures shall be performed only by a qualified physician, dentist or podiatrist within the limits of the defined specific surgical practice privileges that have been granted to that individual by the consulting committee or a committee designated by the consulting committee.
b) Administration of Anesthesia
1) For the purposes of this Section, anesthesia shall include general anesthesia, intravenous sedation, spinal or epidural anesthesia, and any other specific anesthesia technique that is designated by the consulting committee.
2) Anesthesia may be administered only by the following persons, each having been granted specific anesthesia privileges by the consulting committee or a committee designated by the consulting committee:
A) A qualified anesthesiologist (as defined in Section 205.110 of this Part.)
B) A physician licensed to practice medicine in all its branches.
C) A dentist who has been approved by the Department of Financial and Professional Regulation to administer anesthesia for dental surgery only pursuant to Section 8.1 of the Illinois Dental Practice Act [225 ILCS 25].
D) A certified registered nurse anesthetist (as defined in Section 205.110 of this Part) who is implementing the orders of a qualified anesthesiologist, or the physician, dentist, or podiatrist who is performing the procedure. The qualified anesthesiologist, physician, dentist, or podiatrist who has ordered the anesthesia must be on the premises of the facility during the administration of the anesthesia.
E) A registered nurse. If the ASTC policy allows the registered nurse to deliver moderate sedation ordered by a physician licensed to practice medicine in all its branches, podiatrist, or dentist, the following are required:
i) The registered nurse must be under the supervision of a physician licensed to practice medicine in all its branches, podiatrist, or dentist during the delivery or monitoring of moderate sedation and have no other responsibilities during the procedure.
ii) The registered nurse must maintain current Advanced Cardiac Life Support certification or Pediatric Advanced Life Support certification as appropriate to the age of the patient.
iii) The supervising physician licensed to practice medicine in all its branches, podiatrist, or dentist must have training and experience in delivering and monitoring moderate sedation and possess clinical privileges at the ASTC to administer moderate sedation or analgesia.
iv) The supervising physician licensed to practice medicine in all its branches, podiatrist, or dentist must remain physically present and available on the premises during the delivery of moderate sedation for diagnosis, consultation, and treatment of emergency medical conditions.
v) The supervising physician licensed to practice medicine in all its branches, podiatrist, or dentist must maintain current Advanced Cardiac Life Support certification or Pediatric Advanced Life Support certification as appropriate to the age of the patient.
vi) Local, minimal, and moderate sedation shall be defined by the Division of Professional Regulation of the Department of Financial and Professional Regulation. Registered nurses shall be limited to administering medications for moderate sedation at doses rapidly reversible pharmacologically as determined by rule by the Division of Professional Regulation of the Department of Financial and Professional Regulation. (Section 6.7(b) of the Act)
vii) Nothing in the Act or this Section precludes a registered nurse from administering medication for the delivery of local or minimal sedation ordered by a physician licensed to practice medicine in all its branches, podiatrist, or dentist. (Section 6.7(a) of the Act)
F) A podiatrist licensed under the Podiatric Medical Practice Act of 1987. (Section 6.5 of the Act)
3) An anesthesia assistant who is licensed as a physician's assistant pursuant to the Physician Assistant Practice Act of 1987 [225 ILCS 95] may assist in the administration of anesthesia only under the direct supervision of a qualified anesthesiologist (as defined in Section 205.110 of this Part).
4) The person administering anesthesia, or a person who has equivalent practice privileges, shall be present in the facility during the recovery of the patient to whom anesthesia was administered.
c) Examination of Removed Tissues
1) All tissues removed during surgery, except tissues and materials exempted under subsection (c)(3), shall be examined by a consulting pathologist, who shall provide a written report of the examination to the attending physician.
2) A copy of the pathology report shall be filed in the patient's clinical record within seven days after removal of the tissue.
3) The following tissues and materials are exempt from this requirement and do not need to be examined by a pathologist:
A) Foreskin, fingernails, toenails, and teeth that are removed during surgery.
B) Bone, cartilage, and soft tissue removed during the course of surgery and determined by the attending physician not to require pathological examination.
C) Cataract lenses that are removed during the course of eye surgery.
D) Foreign substances (e.g., wood, glass, pieces of metal, including previously inserted surgical hardware) that are removed during surgery.
d) All x-rays, except those exempted by the consulting committee and as specified in the facility's policies and procedures manual, shall be read by a physician, podiatric physician, or dentist, each of whom shall have practice privileges at the facility, or by a consulting radiologist approved by the consulting committee. A copy of the x-ray report shall be filed in the patient's clinical record within seven days.
e) A registered nurse, qualified by training and experience in operating room nursing, shall be present in the operating room and function as the circulating nurse during all invasive or operative procedures requiring aseptic technique. As used in this subsection, "circulating nurse" means a registered nurse who is responsible for coordinating all nursing care, patient safety needs, and the needs of the surgical team in the operating room during an invasive or operative procedure requiring aseptic technique. (Section 6.5(2.5) of the Act)
(Source: Amended at 40 Ill. Reg. 13933, effective September 21, 2016)
Section 205.540 Postoperative Care
a) All patients' postoperative conditions shall be observed and assessed in the facility for a period of time sufficient to ensure that the patient is awake, physiologically stable, manifests no immediate postoperative complications, and is ready to return to home or to a similar environment. Overnight stays are not permissible. Before discharge from the facility, each patient shall be evaluated by a qualified practitioner for proper anesthesia recovery. No patient shall be required to leave the facility in less than one hour following the procedure or procedures. Each post-surgical patient's overall condition shall be assessed and documented in the medical record by a qualified practitioner, showing that the patient is ready for discharge or in need of further treatment or monitoring.
b) Rh factor sensitization prophylaxis shall be provided to all Rh negative patients following procedures performed to terminate pregnancy, in accordance with standard medical procedures.
c) Patients in whom a complication is known or suspected to have occurred during or after the performance of a surgical procedure shall be informed of the complication, and arrangements shall be made for treatment of the complication. If the patient is admitted to a hospital, a summary of care given in the ambulatory surgical treatment center concerning the suspected complication or complications shall accompany the patient.
d) To ensure availability of follow-up care at a hospital, the ambulatory surgical treatment center shall document an effective procedure for the immediate transfer of patients requiring emergency care beyond the capabilities of the ASTC, to a hospital within 15 to 30 minutes travel time of the ASTC.
e) Written instructions shall be issued to all patients in accordance with the standards approved by the consulting committee and shall include the following:
1) Symptoms of complications associated with procedures performed;
2) Limitations and restrictions of activities of the patient;
3) Specific telephone number to be used by the patient, at any time, if any complication or question arises; and
4) A date for a follow-up or return visit after the performance of the surgical procedure, which shall be scheduled within six weeks.
f) When a facility-provided medication is ordered at least 24 hours in advance for surgical procedures and is administered to a patient in an ASTC, any unused portion of the facility-provided medication shall be offered to the patient upon discharge when it is required for continuing treatment.
1) A facility-provided medication shall be labeled consistent with labeling requirements under Section 22 of the Pharmacy Practice Act.
2) If the facility-provided medication is used in an operating room setting, the prescriber is responsible for counseling the patient on its proper use and administration and the requirement of pharmacist counseling is waived. (Section 7d of the Act)
3) For the purposes of this Section, "facility-provided medication" means any topical antibiotic, anti-inflammatory, dilation, or glaucoma drop or ointment that an ASTC has on standby or that is retrieved from a dispensing system for a specific patient for use during a procedure. (Section 15.10 of the Pharmacy Practice Act)
g) Patients shall be discharged only on the written, signed order of a physician. The name, or relationship to the patient, of the person accompanying the patient upon discharge from the facility shall be noted in the patient's medical record.
h) Information on availability of family planning services shall be provided, when desired by the patient, to all patients undergoing a pregnancy termination procedure. When, in the physician's opinion, it is in the best interests of the patient and with the patient's consent, family planning services may be initiated prior to the discharge of the patient.
(Source: Amended at 48 Ill. Reg. 15862, effective October 24, 2024)
Section 205.550 Infection Control
a) Each ASTC shall provide a safe and healthful environment that minimizes infection exposure and risk to patients, health care workers and visitors.
b) Each ASTC shall maintain a written, active and effective facility-wide infection control program. A system designed for the identification, surveillance, investigation, control, and prevention of infectious and communicable diseases in patients and health care workers shall be included in this program.
c) The ASTC shall designate a person as a Qualified Infection Control Professional to develop and implement policies governing the control of infectious and communicable diseases. The means of qualification (i.e., education, training and experience; or certification) shall be documented.
d) Policies and procedures for the reporting and care of cases of communicable diseases shall comply with the Control of Communicable Diseases Code, the Control of Sexually Transmissible Infections Code, and the Control of Tuberculosis Code.
e) The ASTC shall consider, select and implement nationally recognized infection control guidelines in developing its infection control program, including the Centers for Disease Control and Prevention publication "Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings", "Guidelines for Disinfection and Sterilization in Healthcare Facilities" or "Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care"; or the Association of periOperative Registered Nurses (AORN) publication "Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Centers".
1) When patients have a communicable disease, or present signs and symptoms suggestive of communicable disease, precautionary measures shall be taken to avoid cross-infection to personnel, other patients and the public.
2) If an ASTC treats a patient who has a communicable disease, the ASTC shall provide appropriate facilities and equipment for isolation.
3) Policies and procedures for handling infectious cases shall include orders to the medical, nursing and non-professional staff concerning isolation technique.
4) The ASTC shall require that all persons who care for patients with or suspected of having a communicable disease, or whose work brings them in contact with materials that are potential conveyors of communicable disease, comply with the ASTC's infection control program to avoid transmission of the disease agent.
f) The ASTC shall develop and implement comprehensive interventions to prevent and control extensively drug-resistant organisms (XDROs), including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and certain gram-negative bacilli (GNB), that take into consideration guidelines of the Centers for Disease Control and Prevention for the management of XDROs in health care settings, including the "Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings" and "Guidelines for Hand Hygiene in Health-Care Settings".
g) The ASTC shall comply with 42 CFR 416.43 and 416.51 in developing and maintaining an infection control program. Documentation that the ASTC considered, selected and implemented nationally recognized infection control guidelines in developing its infection control program shall be made available to the Department upon request.
h) The ASTC shall develop, implement, monitor and enforce a hand hygiene program.
1) The ASTC shall assess the current practice and compliance, assess current
hand hygiene products, solicit input from clinical staff, and develop a hand hygiene program for all staff.
2) All staff (including contractual and medical) shall be educated in the hand hygiene program during initial orientation and at least annually. This education shall be documented.
3) The program shall have clear goals that require quantitative, time-specific improvement targets.
4) The ASTC shall develop and implement ongoing measurement tools to assure compliance with the program.
5) The results of the monitoring shall be incorporated in the clinical statistical data required in Section 205.620.
i) Contaminated material shall be handled and disposed of in a manner designed to prevent the transmission of the infectious agent.
j) Thorough hand hygiene shall be required after touching any contaminated or infected material.
k) Whenever the Control of Communicable Diseases Code and the Control of Tuberculosis Code require the submission of laboratory specimens for the release of a patient from isolation or quarantine, the specimens shall be submitted to the laboratories of the Illinois Department of Public Health or other laboratory licensed by the Department for the specific tests required.
l) The ASTC shall establish a systematic plan of checking and recording cases of infection, known or suspected, that develop in the ASTC. The cases shall also be reported to the governing body. The ASTC shall investigate health care associated infections to determine the causative organism and its possible sources. The findings and recommendations shall be reported to the medical staff and administration for corrective action.
m) Policies and procedures related to this Section, and including, but not limited to, the following items, shall be developed:
1) The isolation of patients with specific and suspected infectious diseases and protective isolation of appropriate patients.
2) In-service education programs on the control of infectious diseases.
3) Policies and procedures for isolation techniques appropriate to the diagnosis of the patient, and protective routines for personnel and visitors.
4) The recording and reporting of all infections of clean surgical cases to the administration and procedures for the investigation of cases.
(Source: Added at 38 Ill. Reg. 19208, effective September 9, 2014)
SUBPART F: RECORDS AND REPORTS
Section 205.610 Clinical Records and Reports
a) The ASTC shall maintain accurate and complete clinical records for each patient, and all entries in the clinical record shall be made at the time the surgical procedure is performed and when care, treatment, medications, or other medical services are given. The record shall include, but not be limited to, the following:
1) Patient identification;
2) Admitting information, including any patient medical history and physical examination findings as applicable, diagnosis or need for medical services, and all consultation reports;
3) Pre-counseling notes;
4) Signed informed consent;
5) Confirmation of a pregnancy (when an abortion is performed);
6) Signed physician orders;
7) Laboratory test reports, pathologist's report of tissue or other specimens including foreign bodies, and physician's, podiatrist's, dentist's or radiologist's report of imaging studies;
8) An anesthesia record;
9) The operative record, describing techniques, findings and tissues or other items removed or altered, shall be written or dictated immediately following surgery and signed by the surgeon. The operative record shall include, but not be limited to:
A) The name and ASTC identification number of the patient;
B) The date and time of the surgery;
C) The names of the surgeon or surgeons and assistants or other practitioners who performed surgical tasks, including practitioners who performed those tasks under supervision;
D) The pre-operative and post-operative diagnosis;
E) The name of the specific surgical procedure or procedures performed;
F) The type of anesthesia administered;
G) Complications, if any;
H) A description of techniques, findings, and tissues or other items (such as foreign bodies) removed or altered;
I) A description of the specific significant surgical tasks that were conducted by practitioners other than the primary surgeon or practitioner, including, but not limited to, opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues, or monitoring; and
J) Prosthetic devices, grafts, tissues, transplants or devices, if any, that were implanted in, or removed from, the patient;
10) Medication administration and medical treatments that were performed;
11) Recovery room progress notes;
12) Physician and nurse progress notes;
13) The patient's condition at time of discharge;
14) Patient instructions; and
15) Post-counseling notes.
b) The ASTC shall comply with the Pregnancy Termination Report Code.
c) Record Retention
1) The ASTC shall preserve and retain a patient's clinical records, in a format established by the facility's written policy, for not less than 10 years after the date of service. If the patient was a minor on the date the record was produced, the records shall be retained until the patient is 23 years old, or at least 10 years after the date the record was produced, whichever is longer.
2) If the ASTC has been notified in writing by an attorney of pending litigation involving a patient's clinical record before the expiration of that record's retention period, the ASTC shall retain the record until the ASTC receives documentation that the litigation involving the record has been concluded, or for 10 years after the date of service, whichever occurs later. If the litigation involves a patient who was a minor when the record was produced, the ASTC shall retain the record until the patient is 23 years old, or at least 10 years after the date the record was produced, whichever is longer.
3) The ASTC shall retain, for as long as it remains in business, a list of organizational-approved procedures, pursuant to Sections 205.120(b)(10), 205.125(b)(9), and 205.130(a).
4) The ASTC shall retain its sterilizer logs for a minimum of three years.
5) The ASTC shall retain its pharmacy narcotics receipts and inventory for a minimum of three years.
d) An ASTC found in violation of this Section shall be penalized pursuant to Subpart H.
(Source: Amended at 46 Ill. Reg. 14215, effective July 28, 2022)
Section 205.620 Statistical Data
a) Each ambulatory surgical treatment center shall collect, compile and maintain the following clinical statistical data at the facility to be made available to the Department during a survey or inspection, or upon the Department's request:
1) The total number of surgical cases treated by the ASTC;
2) The number of each specific surgical procedure performed;
3) The number and type of complications reported, including the specific procedure associated with each complication;
4) The number of patients requiring transfer to a hospital for treatment of complications. The procedure performed and the complication that prompted each transfer shall be listed;
5) The number of deaths, including the specific procedure that was performed; and
6) The results of the monitoring of the ASTC's hand hygiene program in Section 205.550(h).
b) The clinical statistical data shall be collected, compiled and maintained quarterly, with reports completed no later than January 31, April 30, July 31 and October 31 for the preceding quarter.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
SUBPART G: LIMITED PROCEDURE SPECIALTY CENTERS
Section 205.710 Pregnancy Termination Specialty Centers (Repealed)
(Source: Repealed at 44 Ill. Reg. 18358, effective November 2, 2020)
Section 205.720 Personnel (Repealed)
(Source: Repealed at 14 Ill. Reg. 13802, effective August 15, 1990)
Section 205.730 General Patient Care (Repealed)
(Source: Repealed at 14 Ill. Reg. 13802, effective August 15, 1990)
Section 205.740 Preoperative Requirements (Repealed)
(Source: Repealed at 14 Ill. Reg. 13802, effective August 15, 1990)
Section 205.750 Postoperative Requirements (Repealed)
(Source: Repealed at 14 Ill. Reg. 13802, effective August15, 1990)
Section 205.760 Reports (Repealed)
(Source: Repealed at 14 Ill. Reg. 13802, effective August 15, 1990)
SUBPART H: LICENSURE PROCEDURES
Section 205.810 Complaints
a) The Department shall investigate all complaints received regarding any ambulatory surgical treatment center or any physician practicing in an ambulatory surgical treatment center (except as provided in subsection (d) of this Section). Complaints should preferably be in writing and contain sufficient facts to facilitate the investigation. Complaints by telephone will be accepted.
b) Each ambulatory surgical treatment center shall post a notice provided by the Department which reads: "If you have concerns about the care being provided in this licensed ambulatory surgical treatment center you may file a complaint with the Department of Public Health by writing to the following address: [address], or by calling [telephone number] during regular business hours. You may also wish to discuss your concerns with the personnel available at this facility. This notice is posted as required by regulation of the Department of Public Health." The notice shall be posted in each center in a location visible to staff, patients, visitors, and the general public.
c) Upon receipt of each complaint the Department will, within seven days, acknowledge by letter receipt of the complaint.
d) If the complaint contains allegations that would constitute a prima facie violation of the Act or this Part, an investigation will be conducted. Whenever the complaint concerns matters outside the jurisdiction of the Department or may concern matters that are within the jurisdiction of another agency, the complaint also will be referred to the appropriate agency whenever so doing does not violate patient confidentiality.
e) The Department will investigate each complaint as quickly as possible based on available personnel and resources. Complaints that constitute a threat to the public health will be investigated within ten days of receipt of the complaint.
f) The Department will utilize the most efficient and effective methods to investigate each complaint. This may include inspections pursuant to Section 9 of the Act and the issuance of subpoenas and subpoenas duce tecum pursuant to Section 10g(c) of the Act, when appropriate.
g) Upon the conclusion of the investigation the complainant will be notified of the results of the investigation and any action taken by the Department.
(Source: Amended at 15 Ill. Reg. 17770, effective December 1, 1991)
Section 205.820 Notice of Violation
a) When the Department determines through inspection, review of records, or other means of investigation that a facility is in violation of the Act or this Part, a notice of violation shall be served upon the licensee. The notice shall be served in the manner provided in Section 10g(a) of the Act. (Section 10b of the Act)
b) Each notice of violation shall be in writing and shall include:
1) A description of the nature of the violation.
2) A citation of the statutory provision or rule alleged to have been violated.
3) A description of any action the Department may take under the Act, including the assessment of a penalty under Section 10d of the Act and Section 205.850 of this Part, or adverse licensure action under Section 10f of the Act and Section 205.840 of this Part.
4) A statement that the facility must submit a plan of correction under Section 10c of the Act and Section 205.830 of this Part.
5) A description of the manner in which the facility may contest the notice of violation and the right to a hearing to contest the violation under Section 10g of the Act and Section 205.860 of this Part. (Section 10b of the Act)
(Source: Section repealed, new Section adopted at 15 Ill. Reg. 17770, effective December 1, 1991)
Section 205.830 Plan of Correction
a) Each facility served with a notice of violation under Section 10b of the Act and Section 205.820 of this Part shall submit to the Department a written plan of correction within ten days of receipt of the notice of violation. Such plan of correction shall include:
1) A statement of the specific actions the facility intends to take to correct each violation.
2) The specific date by which each violation will be corrected. (Section 10c of the Act)
b) The facility may submit any additional information in response to the notice of violation which it believes will clarify the condition or alleged violation. The Department will consider the information in reviewing the facility's response and the plan of correction.
c) Each plan of correction is subject to the approval of the Department. The Department will review each plan of correction to determine whether the corrective action is specific, whether the corrective action can reasonably be expected to actually correct the violations and whether the completion date is reasonable. (Section 10c of the Act)
d) If the Department rejects a plan of correction, it shall notify the facility of the rejection and the reason for the rejection. The facility shall have ten days after receipt of a notice of rejection to submit a modified plan of correction. If a modified plan is not timely submitted, or if a modified plan is rejected, the Department shall impose a plan of correction and the facility shall follow the imposed plan of correction. (Section 10c of the Act)
e) The facility may contest the rejection or imposition of a plan of correction and has the right to a hearing to contest the action under Section 10g of the Act and Section 205.860 of this Part. (Section 10b of the Act)
(Source: Section repealed, new Section adopted at 15 Ill. Reg. 17770, effective December 1, 1991)
Section 205.840 Adverse Licensure Action
a) Adverse licensure actions include the denial of an initial license application, denial of an application for license renewal, revocation of a license, imposition of a penalty or fine, service suspension, and emergency suspension.
b) Adverse licensure actions will be considered by the Department under the following conditions:
1) Substantial or continued failure of the licensee, facility, or applicant to comply with the Act or this Part. (Section 10f(a) of the Act)
2) Failure of the licensee, facility, or applicant to demonstrate the capacity to safely provide one or more of its services to patients. (Section 10f(b) of the Act)
3) Violation of any provision of the Act or this Part by conduct which is detrimental to the health, safety, or welfare of a patient or patients.
4) Refusal of the licensee to make payment of a penalty or fine which has been added to the facility's license renewal fee under Section 10e of the Act and Section 205.850(e)(2) of this Part. (Section 10e of the Act)
c) In determining whether to take adverse licensure action pursuant to Section 10f of the Act and the severity of the action, including setting the amount of any fine or penalty, the Department will consider the following factors:
1) The gravity of the violation or violations, including each of the following:
A) The probability that death or serious physical or mental harm to a patient or patients will result or has resulted.
B) The severity of the actual or potential harm to a patient or patients.
C) The extent to which the provisions of the Act, other applicable statutes, or this Part were violated.
2) The reasonable diligence exercised by the licensee, facility, or applicant to avoid the violation or violations or to reduce the potential harm to a patient or patients.
3) Efforts by the licensee, facility, or applicant to correct the violation or violations.
4) Any previous violations committed by the licensee, facility, or applicant.
5) Any financial benefit to the facility of committing or continuing the violation or violations. (Section 10d(b) of the Act)
d) When the Department determines under this Section and Section 10f(a) of the Act to issue an order of license denial, suspension or revocation, or refusal to renew a license, the Department shall notify the licensee, facility, or applicant. The notice shall be served in the manner provided in Section 10g(a) of the Act and shall specify the effective date of the action. (Section 10f(a) of the Act)
e) When the Department determines under this Section and Section 10f(b) of the Act to issue an order of service suspension, the Department shall notify the licensee, facility, or applicant. The notice shall be served in the manner provided in Section 10g(a) of the Act and shall specify the effective date of the action. (Section 10f(b) of the Act)
f) When the Department finds that the public interest, health, safety, or welfare imperatively requires emergency action to suspend specific services, or to deny or revoke a license, the Department shall notify the licensee or facility. The notice shall include a statement of the basis of the emergency action and shall be served in the manner provided in Section 10g(a) of the Act. The order shall take effect immediately, provided that the Department promptly initiates proceedings for license revocation or other action. (Section 10f(c) of the Act)
(Source: Section repealed, new Section adopted at 15 Ill. Reg. 17770, effective December 1, 1991)
Section 205.850 Fines and Penalties
a) When the Department determines to impose a penalty or fine under Section 10d of the Act and Section 205.840 of this Part, the Department shall issue a notice of fine assessment. The notice shall be served in the manner provided in Section 10g(a) of the Act. (Section 10d of the Act)
b) Each notice of fine assessment shall include:
1) A description of the violation or violations for which the fine is assessed. (Section 10d of the Act)
2) The amount of the fine as determined under Section 205.840 of this Part, which may be up to $500 per violation per day commencing on the date the violation was identified and ending on the date the violation is corrected, or action is taken to suspend, revoke or deny renewal of the license, whichever comes first. (Section 10d of the Act)
3) A description of the manner in which the facility may contest the fine assessment and the right to a hearing under Section 10g of the Act and Section 205.860 of this Part.
c) All fines shall be paid to the Department by the licensee within the following time periods:
1) If the assessment is not contested by the licensee, no later than ten days after the notice of assessment.
2) If the assessment is contested under Section 10g of the Act, no later than ten days after the receipt of the Director's final decision, unless the decision is appealed and the order is stayed by court order under Section 11 of the Act. (Section 10e of the Act)
d) If payment has not been made by the licensee within the time periods specified in subsection (c) of this Section, the Department shall issue a written demand for payment. (Section 10e of the Act)
e) If the licensee does not comply with a written demand for payment within 30 days, the Director shall issue an order to do any of the following:
1) Certify to the Comptroller that the delinquent fines are due and owing from the licensee. The certification shall include any amounts due and owing as a result of a civil action pursuant to Section 10e(c) of the Act. The Department shall send notice of the certification to the licensee and to any other person known to the Department who may be affected by the certification.
2) Add the amount of the penalty to the facility's license renewal fee.
3) Bring an action in circuit court to recover the amount of the penalty or fine. (Section 10e of the Act)
(Source: Section repealed, new Section adopted at 15 Ill. Reg. 17770, effective December 1, 1991)
Section 205.860 Hearings
a) Applicants and licensees may appeal certain actions of the Department under the Act and this Part. If a facility desires to contest any Department action, it shall send a written request for a hearing to the Department within 10 days after receipt of the notice of the contested action. Following receipt of a request for a hearing, the Department shall conduct a hearing to review the contested action. (Section 10c(c) of the Act)
b) Hearings conducted pursuant to the Act and this Part shall be conducted in accordance with the following:
1) Sections 10c, 10f, and 10g of the Act.
2) Article 10 of the Illinois Administrative Procedure Act.
3) The Department's rules titled" Practice and Procedure in Administrative Hearings".
c) Applicants and licensees have a right to administrative review of actions and decisions of the Department by the courts under the Administrative Review Law.
(Source: Amended at 38 Ill. Reg. 19208, effective September 9, 2014)
SUBPART I: BUILDING DESIGN, CONSTRUCTION STANDARDS, AND PHYSICAL REQUIREMENTS
Section 205.1310 Plant and Service Requirements
All ambulatory surgical treatment centers are required to meet the following physical plant and service requirements.
a) All proposed facilities shall meet these requirements before licensure will be granted.
b) All existing facilities that are not in compliance with this Section, and subsequent Sections, shall come into compliance no later than May 17, 1984.
(Source: Amended at 7 Ill. Reg. 7640, effective June 14, 1983)
Section 205.1320 General Considerations
a) Location
1) An ambulatory surgical treatment center shall be identifiably separate from other facilities and functions.
2) An ambulatory surgical treatment center may be located within an institution or building which is not primarily devoted to ambulatory surgery and may share facilities and functions with other portions of the institution or building as provided in Sections 205.1350(a) and 205.1390(e). Such centers shall be separated from other portions of the institution or building by at least a one-hour fire separation. Such centers may be located in a physician's office, group practice clinic, or other type of office building, unless routine traffic flow and operation of the other facilities located in the institution or building would interfere with the operation of the center.
b) Narrative Program
1) The sponsor for each project shall provide a narrative program of functions for the facility which contains space requirements, staffing patterns, departmental relationships and other basic information relating to the fulfillment of the institution's objectives. This may be a general or detailed description of each function to be performed, space needed for these functions, hours of operation, number of staff or other occupants of the various spaces, types of equipment required, interrelationship of various functions and spaces, and description of those services necessary for the complete functioning of the facility but which are available elsewhere in the community and, therefore, need not be duplicated in this facility. The narrative program shall explain the type of surgery or procedures, the volume of work, the number of doctors, and the number of other staff.
2) If the center is located in an institution or building which is not primarily devoted to ambulatory surgery, the narrative program shall describe the nature of any other offices and functions located in the institution or building and any steps which will be necessary to insure that routine traffic and operation of such offices and functions do not interfere with the operation of the center.
c) Size. The extent (number and types) of the diagnostic, clinical, and administrative facilities to be provided shall be determined by the services contemplated and the estimated patient load as described in the narrative program.
d) Provisions for the Handicapped. The design shall provide for accessibility by physically handicapped persons (public, staff, and patients).
e) Privacy for Patient. The design of the facility shall provide for the privacy and dignity of the patient during interview, examination, and treatment.
f) An ambulatory surgical treatment center licensed under the Act shall make reasonable efforts to have activated at all times the close captioning feature on a television in a common area provided for use by the general public or in a patient's room, or enable the closed captioning feature when requested to do so by a member of the general public or a patient, if the television includes a closed captioning feature. As used in this subsection (f), "closed captioning" means a text display of spoken words presented on a television that allows a deaf or hard of hearing viewer to follow the dialogue and the action of a program simultaneously.
1) It is not a violation of this subsection (f) if the closed captioning feature is deactivated by a member of the ambulatory surgical treatment center's staff after such feature is enabled in a common area or in a patient's room unless the deactivation of the closed captioning feature is knowing and intentional. It is not a violation of this subsection (f) if the closed captioning feature is deactivated by a member of the general public, a patient, or a member of the ambulatory surgical treatment center's staff at the request of a patient of the ambulatory surgical treatment center.
2) If the ambulatory surgical treatment center does not have a television that includes a closed captioning feature, then the ambulatory surgical treatment center shall ensure that all televisions obtained for common areas and patient rooms include a closed captioning feature. This subsection (f) does not affect any other provision of law relating to disability discrimination or providing reasonable accommodations or diminish the rights of a person with a disability under any other law. (Section 7c of the Act)
(Source: Amended at 46 Ill. Reg. 14215, effective July 28, 2022)
Section 205.1330 New Construction, Additions and Major Alterations
Requirements and procedures for new construction, additions, and major alterations are as follows:
a) Preliminary drawings and outline specifications, whether for new construction or for substantial alterations, shall be submitted to the Department with a program narrative description for review and approval prior to starting final working drawings and specifications.
b) The final working drawings and specifications shall be submitted to the Department for review and approval prior to release of contract documents for bidding. Change orders that affect scope and/or function shall be submitted for approval prior to execution.
c) The Department shall be notified of the award of contracts, and when construction has been completed. Approval by the Department prior to occupancy is required.
d) The preparation and submission of drawings and specifications shall be executed by or be under the immediate supervision of an architect registered in the State of Illinois. Structural drawings and specifications for these systems may be executed by or be under the immediate supervision of a structural engineer licensed in the State of Illinois. Mechanical and electrical drawings and specifications for these systems may be executed by or be under the immediate supervision of a professional engineer licensed in the State of Illinois.
e) First stage submission. Design Development Drawings and Outline Specifications.
f) The preliminary sketch plans shall indicate in detail the assignment of all spaces, size of areas and rooms, indicating in outline the fixed and movable equipment and furniture.
1) The plans shall be drawn at a scale sufficiently large to clearly present the proposed design.
2) The drawings shall include:
A) a plan of each floor including the basement or ground floor,
B) a plan showing roads, parking areas, sidewalks, etc.,
C) elevations of all facades,
D) sections through the building, and
E) all adjacent areas clearly labeled if addition or alteration.
3) The total gross floor area shall be shown on the drawings.
4) Outline specifications shall provide a general description of the construction including finishes; acoustical material, its extent and type; heating and ventilating systems; and the type of elevators.
5) A brief narrative of the proposed program shall be included.
g) Second stage submission. Working Drawings and Specifications.
All working drawings shall be well prepared so that clean and distinct prints may be obtained, shall be accurately dimensioned and shall include all necessary explanatory notes, schedules and legends. Working drawings shall be complete and adequate for contract purposes. Separate drawings shall be prepared for each of the following branches of work: Architectural, Structural, Mechanical, Electrical. They shall include or contain the following:
1) Architectural Drawings.
A) Site plan showing all new topography, newly established levels and grades, existing structures on the site (if any), new buildings and structures, roadways, walks, and the extent of the areas to be landscaped. All structures and improvements that are to be removed under the construction contract shall be shown.
B) Plan of each floor.
C) Elevations of each facade.
D) Sections through building.
E) If elevators and dumbwaiters are provided, drawings are required showing shaft details and dimensions, sizes of cab platforms and doors, travel distances including elevation height of landings, pit sizes, and machine rooms.
F) Special care areas and similar areas shall be detailed at a scale to show the location, type, size and connection of all fixed and movable equipment.
G) Schedule of finishes.
2) Structural Drawings.
A) Plans of foundations, floors, roofs and all intermediate levels shall show a complete design with sizes, sections, and the relative location of the various members. Schedule of beams, girders and columns.
B) Floor levels, column centers, and off-sets shall be dimensioned.
C) Special openings and pipe sleeves shall be dimensioned or otherwise noted for easy reference.
D) Details of all special connections, assemblies and expansion joints shall be given.
E) Notes on design data shall include the name of the governing building code, values or allowable unit stresses, assumed live loads, including wind loads, earthquake load, and soil bearing pressures.
3) Mechanical Drawings. These drawings with specifications shall show the complete heating, cooling and ventilation systems; plumbing, drainage, stand pipe, and sprinkler systems.
A) Heating, Cooling and Ventilation.
i) Any radiators, coils and steam heated equipment, such as sterilizers.
ii) Heating and steam mains and branches with pipe sizes.
iii) Diagram of heating and steam risers with pipe sizes.
iv) Sizes, types and heating surfaces of boilers, furnaces, with stokers and oil burners, if any.
v) Pumps, tanks, boiler breeching and piping and boiler room accessories.
vi) Air conditioning systems with required equipment, water and refrigerant piping, and ducts.
vii) Supply and exhaust ventilating systems with connections and piping.
viii) Air quantities for all room supply and exhaust ventilating duct openings.
B) Plumbing, Drainage and Stand Pipe Systems.
i) Size and elevation of: street sewer, house sewer, house drains, street water main and water service into the building.
ii) Location and size of soil, waste, and vent stacks with connections to house drains, cleanouts, fixtures and equipment.
iii) Size and location of hot, cold and circulating mains, branches, and risers from the service entrance, and tanks.
iv) Riser diagram of all plumbing stacks with vents, water risers and fixture connections.
v) Any gas, oxygen and similar piped systems.
vi) Any stand pipe and sprinkler systems.
vii) All fixtures and equipment that require water and drain connections.
4) Electrical Drawings. Drawings shall show all electrical wiring, outlets, and equipment that require electrical connections.
A) Electrical service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building.
B) Location of main switchboard, power panels, light panels and equipment. Feeder and conduit sizes shall be shown with schedule of feeder breakers or switches.
C) Light outlets, receptacles, switches, power outlets, and circuits.
D) Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets and branch conduits as approved by the telephone company. Where public telephones are used for inter-communication, separate room and conduits for racks and automatic switching equipment shall be provided as required by the telephone company.
E) Fire alarm system with stations, signal devices, control board and wiring diagrams.
F) Emergency electrical system with outlets, transfer switch, source of supply, feeders, and circuits as required by the approved program as required under the electrical requirements of this Part.
(Source: Amended at 25 Ill. Reg. 7471, effective May 31, 2001)
Section 205.1340 Minor Alterations and Remodeling Changes
Minor alterations and remodeling changes which do not affect the structural integrity of the building, or change functional operation, or which do not affect safety, need not be submitted for prior approval.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1350 Administration Department and Public Areas
a) Administration Department and Public Areas are facilities to be provided when indicated by the approved program. The facilities required in subsections (c), (e), (f), (g)(1), and (g)(4) of this Section may be shared with other offices or functions when the center is located in an institution or building not primarily devoted to ambulatory surgery.
b) The entrance to the center, or the entrance to the building in which the center is located, shall be sheltered from the weather, located by grade level and must be able to accommodate wheelchairs and stretchers, if applicable.
c) The lobby shall include, if indicated by the approved program for the facility, the following:
1) wheelchair and cart storage
2) reception and information counter
3) waiting area
4) public toilets
5) public telephone
6) drinking fountain
d) Interview spaces for private interviews relating to social services, credit, and admissions shall be provided.
e) Adequate office space for records, business, meeting, and staff shall be provided.
f) A multipurpose room for conferences, and health education purposes including provisions for showing visual aids shall be provided if required by the program.
g) Storage spaces shall be provided for:
1) office supplies
2) sterile supplies, medical/surgical supplies and equipment
3) pharmaceutical supplies
4) housekeeping supplies and equipment
(Source: Amended at 13 Ill. Reg. 16025, effective November 1, 1989)
Section 205.1360 Clinical Facilities
a) Procedure rooms – Sterile area
1) At least one procedure room with a minimum clear area of 250 square feet and a minimum dimension of 14 feet, exclusive of closet, cabinet, and work counter (whether fixed or movable) shall be provided. A minimum clearance of 3'6" at each side and at both ends of the operating table shall be provided.
2) Any new construction of other procedure rooms shall not be less than 120 square feet with a minimum dimension of 10 feet, exclusive of closet, cabinet, and work counter (whether fixed or movable). A minimum of 3'0" clearance at each side and at both ends of the operating table shall be provided.
3) A communication system connecting with the control station shall be provided.
4) Special features such as medical image viewers, and storage space as required by the program shall be provided.
b) Procedure rooms – Non-sterile area
1) Laser rooms
A) Rooms used solely for procedures where lasers are employed shall have a minimum clear floor area of 100 square feet and a minimum clear dimension of 10 feet, exclusive of vestibule, toilet, closet, and work counter (whether fixed or movable). A minimum 3'0" clearance at each side and both ends of the treatment chair/table shall be provided.
B) If a water-cooling system for the laser equipment is used, a water supply and trapped waste line shall be provided to service the laser.
C) A communication system connected to the control station shall be provided.
2) Gastrointestinal endoscopy rooms
A) Rooms used solely for gastrointestinal endoscopic procedures shall have a minimum clear floor area of 200 square feet and a minimum clear dimension of 12 feet, exclusive of such spaces as vestibule, toilet, closet, and work counter (whether fixed or movable). A minimum 3'0" clearance at each side and at both ends of the treatment table shall be provided.
B) A storage area for overgowns, gloves, masks, and goggles adjacent to the hand-washing lavatory shall be provided.
C) An area for the disposal of overgowns, gloves, masks, and goggles shall be provided.
D) An endoscopic instrument cabinet for easy access and proper maintenance of fiberoptic equipment shall be provided.
E) An instrument processing work area with storage cabinets, work counter, drip rack, and double sink shall be provided.
F) A communication system connected to the control station shall be provided.
c) Recovery rooms
1) Rooms for post-anesthesia recovery for surgical patients shall be provided. These rooms shall be classified as Stage I recovery, Stage II recovery, or combined Stage I and Stage II recovery. For the purpose of this Section, lounge chair means recliner.
A) Stage I or combined Stage I and II recovery rooms
i) Stage I recovery rooms shall include spaces for patients who are recovering from surgical procedures requiring general, spinal or any other type of sedation that requires a more intense level of monitoring.
ii) Stage I recovery rooms shall have a minimum clear area of 70 square feet for single or multiple patient occupancy. The stretchers and lounge chairs shall be arranged so that there is a minimum clear dimension of 3' on the sides of the stretchers or lounge chairs and 4' at the foot of the stretchers or lounge chairs.
B) Stage II recovery rooms
i) Stage II recovery rooms shall include spaces for patients who are able to leave the Stage I recovery room but require additional time for all of the patient's vital signs to be stabilized to the point where the patient may leave the facility. These rooms may also serve those patients who have undergone surgical procedures under local anesthesia.
ii) Stage II recovery rooms shall have a minimum clear area of 50 square feet per station with a minimum clear dimension of 3'0" on both sides and 3' at the foot of the stretchers or lounge chairs.
C) Number of required recovery spaces
i) Each procedure room using general, spinal, or epidural anesthesia, or IV sedation shall be equipped with at least one stretcher for Stage I recovery and two additional stretchers or lounge chairs for Stage II recovery.
ii) Each gastrointestinal endoscopy room shall be equipped with a minimum of one stretcher and one other stretcher or lounge chair.
2) The recovery area shall contain a drug distribution station, hand-washing facility, charting facilities, nurses' station, and storage space for supplies and equipment.
3) The recovery rooms shall have accessibility to a toilet without having to leave the recovery room to reach it. The water closet shall be equipped with a gray diverter valve.
(Source: Amended at 48 Ill. Reg. 15862, effective October 24, 2024)
Section 205.1370 Support Service Areas
a) Controls shall be in place to prohibit unauthorized traffic in the surgical area. Personnel who have a communicable disease shall be excluded from the surgical area.
b) The ASTC shall provide sterilizing facilities with high-speed autoclaves conveniently located in a clean workroom to serve all procedure rooms. Alternate provisions, approved by the governing body, may be made for replacement of sterile instruments during surgery.
c) A drug distribution workroom shall be provided for storage and preparation of medication to be administered to patients.
d) Scrub stations with knee, foot or elbow actuated faucets or with automatic electronic actuated faucets shall be provided near the entrances to, but outside of, the procedure rooms. Scrub facilities shall be arranged to minimize splatter on nearby personnel or supply carts.
e) A soiled workroom for the exclusive use of the surgical suite staff shall be provided. The soiled workroom shall contain a work counter, a sink equipped for hand washing, a waste receptacle, and a linen receptacle. This room may be used for cleaning anesthesia equipment.
f) Fluid waste disposal facilities shall be conveniently located with respect to the general procedure rooms.
g) A clean workroom or a clean supply room is required when clean materials are assembled within the surgical suite prior to use. A clean workroom shall contain a work counter, sink equipped for hand washing, and space for clean and sterile supplies. A clean supply room shall be provided when the narrative program defines a system for the storage and distribution of clean and sterile supplies that would not require the use of a clean workroom.
h) Anesthesia storage facilities shall be provided. Flammable anesthetics are prohibited.
i) Medical gas supply storage with space for reserve nitrous oxide and oxygen cylinders shall be provided, with all tanks properly secured.
j) A storage area for equipment and supplies used in the surgical suite shall be provided. The area shall provide protection against dust, moisture, insects, vermin, and temperature and humidity extremes.
k) Separate facilities for staff and personnel shall be provided for male and female personnel (orderlies, technicians, nurses, and doctors) working within the surgical suite. Each area shall contain separate lockers, toilets, lavatories equipped for hand washing, and space for changing clothes, and a combined lounge area. These areas shall be arranged to provide a one-way traffic pattern so that personnel entering from outside the surgical area can change and move directly into the sterile area in facility-laundered surgical attire.
l) The ASTC shall provide change areas where patients can change from street clothes into hospital gowns in privacy and be prepared for surgery. This shall include lockers, toilets, clothing change or gowning areas, and space for the administration of medications.
m) The stretcher storage area shall be out of the direct line of traffic.
n) A janitor's closet containing a floor receptor or service sink and storage space for housekeeping supplies and equipment shall be provided exclusively for the surgical area.
o) Traffic patterns in the surgical area shall be designed to facilities movement of the patients and personnel into, through and out of defined areas, including restricted and semi-restricted areas. Traffic flow shall be tailored to the types of procedures offered in the ASTC.
1) Restricted area: traffic is restricted to authorized personnel and patients. No street clothing shall be worn in the restricted area. Health care workers shall wear facility-laundered surgical attire. Head and facial hair shall be contained within a protective covering. Cloth head coverings shall be laundered by the facility and changed daily. Additional garments shall be completely contained or covered within the surgical attire. Masks shall be worn in restricted areas where open sterile supplies or equipment are present or scrubbed persons are located.
2) Semi-restricted area: traffic is restricted to authorized personnel and patients. No street clothing shall be worn in the semi-restricted area. Health care workers shall wear facility-laundered surgical attire. Head and facial hair shall be contained within a protective covering. Cloth head coverings shall be laundered by the facility and changed daily. Additional undergarments shall be completely contained or covered within the surgical attire. Masks are not required in this area. Patients shall wear attire appropriate for their surgical procedure and shall wear hair covering if applicable.
p) Signage shall clearly delineate the traffic flow and surgical attire requirements.
q) The movement of clean and sterile items shall be separated from contaminated or dirty items by space or traffic patterns.
r) All jewelry shall be removed prior to the surgical scrub. Jewelry shall not be worn in the operating room, except that anesthesia personnel may wear a watch.
s) Additional personal protective equipment shall be worn when exposure to blood or other potentially infectious material is anticipated.
t) Whenever surgical attire or personal protective equipment is soiled, it shall be removed and discarded prior to leaving the surgical area.
u) The sterile gown and gloves used when participating in surgical procedures shall be removed and discarded.
v) The unsterile gloves worn when participating in surgical procedures shall be removed and discarded prior to leaving the operating room.
w) The use of single-use coverall suits shall be determined by ASTC written policy.
x) Shoe covers shall be worn when it can reasonably be anticipated that splashes or spills may occur. If shoe covers are worn, they shall be changed whenever they become torn, wet or soiled; or daily, whichever comes first. They shall be removed and discarded before leaving the surgical area.
y) The use of cover gowns for covering the surgical attire when outside of the surgical area shall be determined by ASTC written policy. Surgical attire worn into the facility from outside shall be changed before entering the operating room. Persons exiting the facility shall don facility-laundered surgical attire upon return to the surgical area.
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)
Section 205.1380 Diagnostic Facilities
a) Radiographic Suite: if radiographic studies are conducted, the following shall apply:
1) Radiographic rooms shall have a minimum clear area of 120 square feet and a minimum clear dimension of 10', exclusive of vestibule, toilet, closet, cabinet, and work counter (whether fixed or movable). A minimum of 3'0" clearance shall be at each side and both ends of the radiographic table;
2) A handwashing sink with a plaster trap within the room;
3) A communication system connected to the control station;
4) A film processing area with work counters, triple sink, storage cabinets, exhaust venting for chemicals, open drains, and safety lighting, if required by the facility operational narrative;
5) A viewing and administration area;
6) Film storage facilities, if required by the facility operations narrative;
7) A toilet room with handwashing facilities, directly accessible from each radiographic room without entering the general corridor area; and
8) A dressing area with convenient access to toilets and a lockable closet unit for patient's belongings.
b) If laboratory testing is performed in the facility, the laboratory area of the facility shall contain the following minimum facilities:
1) A laboratory work counter with sink and vacuum, and electric services.
2) A lavatory or counter sink equipped for handwashing.
3) A storage cabinet or closet for any necessary laboratory supplies and equipment. This storage area may be combined with other storage areas in the center.
4) Blood collection facilities with space for a chair and work counter.
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)
Section 205.1390 Other Building Services
a) Engineering service and equipment areas shall have sufficient space for equipment rooms for boilers, furnaces, mechanical equipment, and electrical equipment.
b) Waste processing services shall be provided for the sanitary storage and disposal of waste by mechanical destruction, compaction, containerization, removal, or by a combination of these techniques.
c) Storage rooms for building maintenance supplies and yard equipment shall be provided.
d) Janitor's closets shall be provided with a floor receptor or service sink.
e) The facilities required in subsections (a), (b), (c), and (d) may be shared with other offices or functions when the center is located in an institution or building not primarily devoted to ambulatory surgery.
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)
Section 205.1400 Details and Finishes
a) Corridors and Exits
1) Minimum public corridor width shall be 5'0", except that corridors and aisles where patients are transported in stretchers or carts shall be 8'00" within the physical boundaries of the facility.
2) The facility or, if the ASTC is within a medical office building, the section shall have at least two exits that are remote from each other.
3) Items such as drinking fountains, telephone booths, vending machines, and portable equipment shall be located so as not to restrict corridor traffic or reduce the corridor width below the required minimum.
b) Doors
1) All doors to toilets that may be used by patients shall be equipped with hardware that will permit access in an emergency.
2) The minimum width of doors for patient access to examination and treatment rooms shall be 3'0".
3) The minimum width of doors to rooms needing access for stretchers (e.g., procedure rooms, recovery) shall be 3'8".
4) Doors on all openings between corridors and rooms or spaces subject to occupancy, except elevator doors, shall be swing type.
c) Doors, sidelights, borrowed lights, and windows in which the glazing extends down to within 18" above the floor (creating the possibility of accidental breakage by pedestrian traffic) shall be glazed with safety glass, wire glass, or plastic glazing material that will resist breaking and will not create dangerous cutting edges when broken, in accordance with the Safety Glazing Materials Act. Similar materials shall be used in wall openings unless required otherwise for fire safety.
d) Thresholds and expansion joint covers shall be made flush with the floor surface to facilitate use of wheelchairs and carts.
e) Paper towel dispensers and waste receptacles shall be provided at all hand-washing fixtures.
f) Labeled fire doors, when required, shall be certified by an independent testing laboratory as meeting the construction requirements equal to those for fire doors in NFPA 80. Reference to a labeled fire door shall be construed to include labeled frame and hardware.
g) Radiation protection requirements of X-ray and gamma-ray installations shall conform to the requirements of the Illinois Emergency Management Agency's rules titled General Provisions for Radiation Protection (32 Ill. Adm. Code 310), Standards for Protection Against Radiation (32 Ill. Adm. Code 340) and Use of X-rays in the Healing Arts Including Medical, Dental, Podiatry, and Veterinary Medicine (32 Ill. Adm. Code 360). Provisions shall be made for testing and completed installation before use, and all defects shall be corrected before use.
h) The minimum ceiling height shall be 8'0" with the following exceptions:
1) Boiler rooms, if provided, shall have ceiling clearance not less than 2'0" above the main boiler header and connecting piping.
2) Radiographic and other rooms containing ceiling-mounted equipment and including those with ceiling-mounted surgical light fixtures shall have height required to accommodate the equipment and fixture.
3) Ceilings in corridors, storage rooms, toilet rooms, and other minor rooms may be not less than 7'8".
4) Suspended tracks, rails, and pipes located in the path of normal traffic shall be not less than 6'8" above the floor.
i) Flammable anesthetics are prohibited.
j) Cubicle curtains and draperies shall be noncombustible or rendered flame retardant and shall pass both the large- and small-scale tests of NFPA 701.
k) Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved.
1) In all areas frequently subject to wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions.
2) Floors that are subject to traffic while wet shall have a nonslip surface.
l) Wall finishes shall be washable and, in the immediate area of plumbing fixtures, shall be smooth and moisture resistant.
m) Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed.
n) Ceiling Finishes
1) Ceilings shall be cleanable and those in sensitive areas such as surgical rooms shall be readily washable and without crevices that can retain dirt particles. These sensitive areas shall have a finished ceiling, covering all overhead ductwork and piping.
2) Finished ceilings may be omitted in mechanical and equipment spaces, shops, general storage areas, and similar spaces, unless required for fire-resistive purposes.
3) Acoustical ceilings are recommended in corridors, multipurpose rooms, and waiting areas.
o) For dates of materials incorporated by reference, see Section 205.115.
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)
Section 205.1410 Construction, Including Fire-Resistive Requirements, and Life Safety
Buildings shall meet the construction requirements and life safety requirements established in Chapters 20 and 21 of NFPA 101 (see Section 205.115(a)(1)(B)).
(Source: Amended at 34 Ill. Reg. 7915, effective May 25, 2010)
SUBPART J: MECHANICAL
Section 205.1510 General
a) Mechanical systems shall be tested, balanced, and operated to demonstrate that the installation and performance of these systems conform to the requirements of these Standards.
b) Upon completion of the contract, the owner shall be provided with a complete set of manufacturer's operating, maintenance and preventive maintenance instructions, and parts list with numbers and description for each piece of equipment. The owner shall also be provided with instruction in the operational use of the systems and equipment as required.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1520 Thermal and Acoustical Insulation
a) Insulation shall be provided for the following within the building:
1) Boilers, smoke breeching and stacks.
2) Steam supply and condensate return piping.
3) Hot water piping above 180°F and all hot water heaters.
4) Hot water piping above 120°F that is exposed to contact by patients.
5) Chilled water, refrigerant, other process piping and equipment operating with fluid temperatures below ambient dew point.
6) Water supply and drainage piping with fluid temperatures below ambient dew point.
7) Air ducts and casings with outside surface temperature below ambient dew point.
8) Other piping, ducts, and equipment necessary to maintain the efficiency of the system.
b) Insulation may be omitted from hot water and steam condensate piping not subject to contact by patients when the insulation is unnecessary for preventing excessive system heat loss or excessive heat gain in the surrounding space.
c) Insulation on cold surfaces shall include an exterior vapor barrier.
d) Insulation, including finishes and adhesives on exterior surfaces of ducts, pipes, and equipment, shall have a flame spread rating of 25 or less and a smoke developed rating of 450 or less as determined by an independent testing laboratory in accordance with ASTM E 84. Exception: Duct, pipe, and equipment coverings shall not be required to meet these requirements where they are located entirely outside the building, or do not penetrate a wall or roof, or do not create an exposure hazard.
e) Linings in air ducts and equipment shall meet the erosion test method described in UL Pub. No. 181. These linings, including coatings and adhesives, and insulation on exterior surfaces of pipes and ducts in building spaces used as air supply plenums, shall have a flame spread rating of 25 or less and a smoke developed rating of 450 or less as determined by an independent testing laboratory in accordance with ASTM E 84.
f) Duct linings shall not be used in systems supplying procedure and recovery rooms/areas.
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)
Section 205.1530 Steam and Hot Water Systems
a) Boilers and/or hot water heaters shall have the capacity, based upon the net ratings published by the Hydronics Institute, to supply the normal requirements of all the systems and equipment.
b) Supply and return mains and risers of space heating and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1540 Air Conditioning, Heating and Ventilating Systems
a) The systems shall be designed to provide the comfort temperatures and humidities as recommended by American Society of Heating, Refrigerating, and Air Conditioning Engineers (ASHRAE) Standards (see Section 205.115(a)(1)(A)).
b) Air handling systems shall conform to NFPA 90A.
c) Heating, air conditioning, and ventilating systems for spaces not exceeding 25,000 cubic feet in volume shall conform to NFPA 90B, except that return ducts shall be constructed of materials equal to that specified for supply ducts, Chapter 2, paragraph 1.1., Duct Materials.
d) Outdoor air intakes shall be located as far as practical, but not less than 15 feet, from exhaust outlets of ventilation systems, combustion equipment stacks, medical-surgical vacuum systems, and plumbing vent stacks, or from areas that may collect vehicular exhaust and other noxious fumes.
e) All ventilation air outlets and inlets shall conform to NFPA 90A, Chapter 2, paragraph 3.2., Location of Outlets and Inlets.
f) The ventilation systems shall be designed and balanced to provide the ventilation and pressure relationships as shown in Table A.
g) The ventilation air supplied to the procedure rooms shall be delivered at or near the ceiling of the area served, and all exhaust or return air from the area shall be removed near the floor level. At least two exhaust outlets shall be used in each procedure room.
h) All central ventilation or air conditioning systems shall be equipped with filters having efficiencies not less than those specified in the following table:
TABLE A
|
FILTER EFFICIENCIES FOR CENTRAL VENTILATION AND AIR CONDITIONING SYSTEMS IN AMBULATORY SURGICAL TREATMENT FACILITIES |
|||
|
|
|||
|
|
|||
|
|
|
Filter Efficiencies (Percent) |
|
|
Area Designation |
Minimum Number of Filter Beds |
Filter Bed No. 1 |
Filter Bed No. 2 |
|
|
|
|
|
|
Procedure and Recovery Rooms |
2 |
25 |
90 |
|
|
|
|
|
|
All Other Areas |
1 |
25 |
-- |
i) All filter efficiencies shall be average atmospheric dust spot efficiencies tested in accordance with the ASHRAE Standards 52.1, 52.2, 55, 58, 62, 63.1, 63.2, 64, and 68.
j) For systems serving procedure and recovery rooms, filter bed No. 1 shall be located upstream of the air conditioning equipment, and filter bed No. 2 shall be located downstream of the supply fan and air conditioning equipment, including humidifiers.
k) Filter frames shall be durable and shall provide an airtight fit with the enclosing duct work. All joints between filter segments and enclosing duct work shall be gasketed or sealed to provide a positive seal against air leakage.
l) A manometer shall be installed across each filter bed serving procedure and recovery rooms.
m) Fire and smoke dampers shall be constructed, located and installed in accordance with the requirements of NFPA 90A.
n) All systems, regardless of size, that serve more than one smoke or fire zone shall be equipped with smoke detectors to shut down fans automatically as specified in paragraph 4-3.1 of NFPA 90A.
o) The ventilation system for anesthesia storage rooms shall conform to the requirements of NFPA 99, including the gravity option ventilation system.
p) Boiler rooms shall be provided with sufficient outdoor air to maintain combustion rates of equipment and limit temperatures in working stations to 97˚F Effective Temperature as defined by the ASHRAE Handbook of Fundamentals.
q) Rooms containing heat-producing equipment, such as boiler rooms and heater rooms, shall be insulated and ventilated to prevent any floor surface above from exceeding a temperature of 100˚F.
r) For dates of materials incorporated by reference, see Section 205.115.
(Source: Amended at 34 Ill. Reg. 7915, effective May 25, 2010)
SUBPART K: PLUMBING AND OTHER PIPING SYSTEMS
Section 205.1610 General
All plumbing systems shall be designed and installed in accordance with the requirements of the Illinois Plumbing Code (77 Ill. Adm. Code 890).
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1620 Plumbing Fixtures
a) Plumbing fixtures shall be of nonabsorptive acid-resistant materials.
b) The water supply spout, for lavatories and sinks required for filling pitchers, for medical and nursing staff handwashing, shall be mounted so that its discharge point is a minimum perpendicular distance of 5 inches above the rim of the fixture.
c) All fixtures for use by medical and nursing staff shall be trimmed with valves which can be operated without the use of hands.
1) When blade handles are used for this purpose, the blade handles shall not exceed 4½ inches in length.
2) The scrub sinks for surgery shall be trimmed with valves which are aseptically operated (i.e., knee or foot or elbow actuated) without the use of hands. Wrist blade handles are not acceptable.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1630 Water System
a) Water systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand periods.
b) Each water service main, branch main, riser, and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.
c) Approved backflow preventers or vacuum breakers shall be installed on hose bibbs, laboratory sinks, janitors' sinks, and on all other fixtures to which hoses or tubing are, or can be attached.
d) Water distribution systems shall be arranged to provide hot water at each hot water outlet at all times.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1640 Drainage Systems
a) Building sewers shall discharge into a community sewage system.
b) Where a community sewage system is not available, sewage and liquid wastes shall be collected, treated and disposed of in a private treatment system which must conform to local and State regulations.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1650 Identification
All piping for, heating, ventilating and air conditioning, and service water systems shall be coded and marked for easy identification.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
SUBPART L: ELECTRICAL
Section 205.1710 General
a) All material including equipment, conductors, controls, and signaling devices shall be installed to provide a complete electrical system with the necessary characteristics and capacity to supply the required electrical facilities. All materials shall be listed as complying with available standards of Underwriters' Laboratories, Inc., or other similarly established standards.
b) All electrical installations and systems shall be tested to show that the equipment is installed and operates as required. A written record of performance tests on special electrical systems and equipment shall be supplied to the owner. Such tests shall show compliance with the governing codes and shall include grounding continuity and alarm systems.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1720 Switchboards and Power Panels
Circuit breakers or fusible switches that provide disconnecting means and overcurrent protection for conductors connected to switchboards and panelboards shall be enclosed or guarded to provide a dead-front type of assembly.
a) The main switchboard shall be located in a separate enclosure accessible only to authorized persons.
b) The switchboards shall be convenient for use, readily accessible for maintenance, clear of traffic lanes, and in a dry ventilated space free of corrosive fumes or gases.
c) Overload protective devices shall be suitable for operating properly in the ambient temperature conditions.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1730 Panelboards
Panelboards serving lighting and appliance circuits shall be located on the same floor as the circuits they serve. This requirement does not apply to any emergency system circuits.
(Source: Amended at 6 Ill. Reg. 6220, effective May 17, 1982)
Section 205.1740 Lighting
a) All spaces occupied by people, machinery, and equipment within buildings, approaches to the buildings, and parking lots shall have lighting.
b) A portable or fixed examination light shall be provided in each examination and treatment room.
c) Procedure rooms shall have general lighting, in addition to local lighting provided by adequate lighting units at the procedure tables.
(Source: Amended at 18 Ill. Reg. 17250, effective December 1, 1994)
Section 205.1750 Receptacles (Convenience Outlets)
a) Duplex grounding type receptacles shall be installed in all areas or rooms in sufficient quantities for the tasks to be performed.
b) The duplex receptacles for general procedures and minor procedures such as laser or endoscopy must be hospital grade.
c) A minimum of two duplex receptables shall be located convenient to each examination and work table, and to each Stage I recovery space.
d) A minimum of one duplex receptacle for each wall shall be installed in each work area or room, other than storage or locker room.
e) Duplex receptables for cleaning equipment and general use shall be installed in all corridors.
(Source: Amended at 18 Ill. Reg. 17250, effective December 1, 1994)
Section 205.1760 Grounding
In areas used for patient care or treatment, all receptacles operating at over 100 volts shall be grounded by an insulated copper conductor, sized in accordance with Table 250-95 of NFPA 70 (see Section 205.115(a)(1)(B)), and installed with the branch conductors supplying these receptacles.
(Source: Amended at 34 Ill. Reg. 7915, effective May 25, 2010)
Section 205.1770 Equipment Installation in Special Areas
a) X-ray Installations. Fixed and mobile X-ray equipment installations, if installed, shall conform to Article 660 of NFPA 70 (see Section 205.115(a)(1)(B)).
b) Installation in non-flammable anesthetizing locations of all electrical equipment and devices, receptacles, and wiring shall comply with NFPA 70. Exception: Isolated electrical systems are not required.
c) An "In Use" warning light or sign shall be installed immediately outside of the entrance to a procedure room in which laser equipment is used when such warning light or sign is required by the manufacturer's specifications.
(Source: Amended at 34 Ill. Reg. 7915, effective May 25, 2010)
Section 205.1780 Emergency Electric Service
a) An emergency source of electricity shall be provided.
b) Ambulatory surgical treatment centers that do not administer inhalation anesthetics in any concentration, or that have no patients requiring electrical life-support equipment, shall be permitted to use a battery system for emergency power. The following are required:
1) Illumination of means of egress as required in NFPA 101;
2) Illumination of procedure and recovery rooms;
3) Illumination of exit and exit directional signs; and
4) Fire alarm and alarms required for nonflammable medical gas systems, if nonflammable medical gas systems are installed.
c) Ambulatory surgical treatment centers in which inhalation anesthetics are administered in any concentration to patients or that have patients requiring electrically operated or mechanical life support devices shall be provided with an emergency generator. This generator shall supply a limited amount of lighting and power service that is essential for life safety and orderly cessation of a procedure during the time normal service is interrupted for any reason. The maximum time of automatic transfer is 10 seconds. The following are required:
1) Task illumination that is related to the safety of life and that is necessary for the safe cessation of procedures in progress;
2) All anesthesia and resuscitative equipment used in areas where inhalation anesthetics are administered to patients must include alarms and alerting devices;
3) Illumination of means of egress as required in the NFPA 101;
4) Illumination of exit and directional signs;
5) Fire alarm and nonflammable medical gas system alarms, if nonflammable medical gas systems are installed; and
6) General illumination and selected receptacles in the vicinity of the generator set.
(Source: Amended at 34 Ill. Reg. 7915, effective May 25, 2010)
Section 205.1790 Fire Alarm System
A manually operated electrically supervised fire alarm system shall be installed. The following is required:
a) Manual pull stations at all exit doors.
b) Audio/visual signal devices in compliance with the State of Illinois Accessibility Code (71 Ill. Adm. Code 400).
c) A presignal system is not permitted; all signals must automatically transmit to the nearest fire department or central receiving station.
d) If a sprinkler system is installed, the required water flow alarm device and electrical tamper switches must be interconnected to the fire alarm system.
e) If a smoke barrier is installed, the doors must normally be kept closed or, if held open, they must be equipped with magnetic hold-open devices that will release the door upon activation of the fire alarm system and a local smoke detector.
f) Automatic smoke detectors are required in waiting areas that are open to egress corridors.
(Source: Amended at 18 Ill. Reg. 17250, effective December 1, 1994)
Section 205.TABLE A General Pressure Relationships and Ventilation Rates of Ambulatory Surgery Area
|
Area Designation |
Pressure Relationship to Adjacent Areas |
Minimum Total Air Changes per Hour Supplied to Room |
All Air Exhausted Directly to Outdoors |
Recirculated Within Room Units |
|
|
|
|
|
|
|
Procedure Room |
+ |
15 |
Optional |
No |
|
Examination Room |
0 |
6 |
Optional |
Optional |
|
Recovery Room |
+ |
6 |
Optional |
Optional |
|
Medication Area |
+ |
4 |
Optional |
Optional |
|
Medical Imaging Room |
0 |
6 |
Optional |
Optional |
|
Soiled Workroom or Soiled Holding |
- |
10 |
Yes |
No |
|
Clean Workroom or Clean Holding |
+ |
4 |
Optional |
Optional |
|
Darkroom |
- |
10 |
Yes |
No |
|
Toilet Room |
- |
10 |
Yes |
No |
|
Janitors' Closet |
- |
10 |
Yes |
No |
|
Sterilizer Equip. Rm. |
- |
10 |
Yes |
No |
|
Linen and Trash Rm. |
- |
10 |
Yes |
No |
|
Laboratory |
- |
6 |
Optional |
Optional |
|
Soiled Linen Storage |
- |
10 |
Yes |
No |
|
Clean Linen Storage |
+ |
2 |
Optional |
Optional |
|
Anesthesia Storage |
0 |
8 |
Yes |
No |
|
Central Services Area |
|
|
|
|
|
Soiled Area |
- |
6 |
Yes |
No |
|
Clean Area |
+ |
4 |
Optional |
Optional |
|
Equipment Storage |
0 |
2 |
Optional |
Optional |
|
+ = Positive |
||||
|
- = Negative |
||||
|
0 = Equal |
||||
(Source: Amended at 48 Ill. Reg. 13763, effective August 28, 2024)