DEPARTMENT OF PUBLIC HEALTH

NOTICE OF ADOPTED AMENDMENTS

1) Heading of the Part: Ambulatory Surgical Treatment Center Licensing Requirements

2) Code Citation: 77 Ill. Adm. Code 205

4) Statutory Authority: Implementing and authorized by the Ambulatory Surgical Treatment Center Act [210 ILCS 5].

5) Effective Date of Rules: July 28, 2022

6) Does this rulemaking contain an automatic repeal date? No

7) Does this rulemaking contain incorporations by reference? No

8) A copy of the adopted amendments, including any material incorporated by reference, is on file in the agency's principal office and is available for public inspection.

9) Notice of Proposal Published in Illinois Register: 46 Ill. Reg. 6213; April 22, 2022

10) Has JCAR issued a Statement of Objection to these rules? No

11) Differences between proposal and final version: The Department updated statutory language in the definitions for "surgical smoke plume" and "surgical smoke plume evacuation system" pursuant to changes made in Public Act 102-0750. In response to public comments received, the Department amended language in Section 205.410 (Equipment and Related Policies) to clarify requirements regarding procedures that require the use of a surgical smoke plume evacuation system and training required for surgical team members. The Department also amended language in this Section, in response to public comments, to clarify that respiratory protection requirements shall follow hospital's respiratory protection plan and to clarify requirements for the use of the surgical smoke plume evacuation system prior to and during a procedure. In addition to changes made in response to public comment, the Department made all changes requested by JCAR, including various typographical, grammatical, and form changes.

12) Have all the changes agreed upon by the agency and JCAR been made as indicated in the agreements issued by JCAR? Yes

13) Will this rulemaking replace an emergency rule currently in effect? No

14) Are there any rulemakings pending on this Part? No

15) Summary and Purpose of Rulemaking: This rulemaking includes statutory requirements pursuant to Public Acts 102-0533 and 102-0750 regarding the use of surgical smoke plume evacuation systems and Public Act 101-0116 regarding the enabling of closed captioning feature on televisions in public areas. In addition to the statutory requirements, this rulemaking also amends the Ambulatory Surgical Treatment Center Licensing Requirements to align with federal Centers for Medicare and Medicaid Services (CMS) regulations that reduce administrative burden and increase efficiency and transparency.

16) Information and questions regarding this adopted rulemaking shall be directed to:

Department of Public Health
Attention: Tracey Trigillo, Rules Coordinator
Lincoln Plaza
524 South 2nd Street, 6th Floor
Springfield, IL 62701

(217) 782-1159
dph.rules@illinois.gov

The full text of the Adopted Amendments begins on the next page:

TITLE 77: PUBLIC HEALTH

CHAPTER I: DEPARTMENT OF PUBLIC HEALTH

SUBCHAPTER b: HOSPITAL AND AMBULATORY CARE FACILITIES

PART 205

AMBULATORY SURGICAL TREATMENT CENTER LICENSING REQUIREMENTS

SUBPART A: GENERAL PROVISIONS

SUBPART B: OWNERSHIP AND MANAGEMENT

SUBPART C: PERSONNEL

SUBPART D: EQUIPMENT, SUPPLIES, AND FACILITY MAINTENANCE

SUBPART E: GENERAL PATIENT CARE

SUBPART F: RECORDS AND REPORTS

SUBPART G: LIMITED PROCEDURE SPECIALTY CENTERS

SUBPART H: LICENSURE PROCEDURES

SUBPART I: BUILDING DESIGN, CONSTRUCTION STANDARDS, AND PHYSICAL REQUIREMENTS

SUBPART J: MECHANICAL

SUBPART K: PLUMBING AND OTHER PIPING SYSTEMS

SUBPART L: ELECTRICAL

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.

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, or the ID/DD Community Care 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 46 Ill. Reg. 14215, effective July 28, 2022)

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 "Perioperative Standards and Recommended Practices for Inpatient and Ambulatory Centers". 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 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) 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 (f) 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 46 Ill. Reg. 14215, effective July 28, 2022)

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 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.

ca) If a patient is medically evaluated, examined and 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 specific health information, if available, shall be included in made part of the patient's clinical record at the time of the patient's registration and admission to the ASTC patient is registered and admitted to the ambulatory surgical treatment center.

db) 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 An up-to-date medical history and complete physical examination shall be obtained before beginning any medical procedure. The history and examination shall be documented in the patient's medical record. Upon admission, each patient shall have a pre-surgical assessment completed by a physician or other qualified practitioner. If patient records are available, changes in the patient's condition since completion of the most recently documented medical history and physical assessment, including any allergies to drugs and biologicals, shall be documented. A preanesthetic evaluation shall be completed specifically identifying any patient sensitivity or contraindications to anesthesia.

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.

gc) 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.

hd) 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.

ie) 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.

jf) 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.

kg) 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 205.540 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. provide written documentation of one of the following:

1) A transfer agreement with a hospital within approximately 15-30 minutes travel time of the facility;

2) A statement that the medical director of the facility has full admitting privileges at a hospital within approximately 15-30 minutes travel time and that he/she will assume responsibility for all facility patients requiring follow-up care; or

3) A statement that each staff physician, dentist, or podiatrist has admitting privileges in a hospital within 15-30 minutes travel time of the facility.

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) 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.

g) 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 46 Ill. Reg. 14215, effective July 28, 2022)

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)

SUBPART I: BUILDING DESIGN, CONSTRUCTION STANDARDS, AND PHYSICAL REQUIREMENTS

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)