Section 205.420  Sanitary Facility

a)         The ambulatory surgical treatment center shall insure maintenance of a sanitary facility with all equipment in good working order.  Written procedures shall include provision for 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 of three 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 AIDS or ARC as defined in 77 Ill. Adm. Code 693.20, shall be disposed of by the center in accordance with subsection (c) of this Section, or delivered in accordance with subsection (d) of this Section to a research facility to use such blood, blood components, organs, semen, or other human tissue for AIDS research.

c)         Any such blood, blood components, organs, semen, or other human tissue, and any other materials or paraphenalia exposed to, or contaminated by, such blood, blood components, organs, semen, or other human tissue shall be completely incinerated, sterilized, or sealed in order to render the materials innocuous before disposal or removal from the premises.

1)         The incineration of materials shall be done in accordance with the requirements of the Pollution Control Board concerning the operation of an incinerator (35 Ill. Adm. Code 724).

2)         The sterilization of materials shall be done by autoclaving the materials 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 which have not been incinerated or sterilized shall be disposed of by a waste hauler with a proper permit from the Illinois Environmental Protection Agency under rules of the Pollution Control Board (35 Ill. Adm. Code 809). These materials must be sealed, transported, and stored in biohazard containers. These 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. These containers shall be lined with one or two high density polyethylene or polypropylene plastic bags with a total tickness of at least 2.5 mil. or equivalent material. The containers shall be sealed before being removed from the facility.

d)         When a center delivers such blood, blood components, organs, semen, or other human tissue to a research facility, the center shall file a report with the Department (Division of Laboratories) which 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 licensed under the Clinical Laboratory Act (Ill. Rev. Stat. 1987, ch. 111½, par. 621 et seq.), any blood bank licensed under the Illinois Blood Bank Act (Ill. Rev. Stat. 1987, ch. 111½, par. 601-101 et seq.) or any hospital licensed under the Hospital Licensing Act (Ill. Rev. Stat. 1987, ch. 111½, par. 142 et seq.)

(Source:  Amended at 12 Ill. Reg. 15573, effective October 1, 1988)