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)