Section 460.500  Handling and Disposal of HIV Contaminated Blood

a)         Any blood or blood components showing exposure to HIV as evidenced by two or three reactive ELISA test results (according to the package insert – product circular) or any other identified causative agent of AIDS or originating from a patient diagnosed with AIDS or AIDS-Related Complex (ARC) as defined in 77 Ill. Adm. Code 693.20, shall be disposed of in accordance with the provisions of this Section, unless a research facility licensed by the state requests, in writing, the use of such blood for AIDS research.  (Section 3.1 of the Act.)  Any such blood or human tissue shall be disposed of in accordance with Section 460.500 (b) when no longer being used for research purposes.

1)         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.).

2)         Any person delivering such blood or blood components to research facilities pursuant to such a request shall file with the Department a report which shall include at least the following information:

A)        a copy of the request for blood or blood components;

B)        the quantity of blood or blood components delivered;

C)        the name and location of the research facility to which the blood or blood components was delivered; and

D)        the date and time of delivery.  (Section 620-3.1 of the Act.)

b)         Any such blood or blood components or any materials or paraphernalia exposed to or contaminated by such blood or blood components shall be disposed of in accordance with the following provisions:

1)         Cultures and specimens to be discarded, and all other potentially infectious materials, shall be completely incinerated or sterilized or sealed in order to render the materials innocuous before disposal or removal from the premises.

2)         The incineration of materials shall be done in accordance with the requirements of the Illinois Environmental Protection Agency concerning the operation of an incinerator.  (35 Ill. Adm. Code 700).

3)         The sterilization of materials shall be done by autoclaving the materials in accordance with the manufacturer's recommendations, and the effectiveness of the autoclave shall be verified and documented at least weekly with a biological spore assay containing B. stearothermophilus.

4)         The disposal or removal of materials outside of the facility shall be done in the following manner:

A)        Incinerated or sterilized materials shall be disposed of through routine waste disposal methods without precautions against possible contamination.

B)        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.  (35 Ill. Adm. Code 809).  The materials which have not been sterilized 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 polyethyene or polypropylene plastic bags with a total thickness of at least 2.5 mil. or equivalent material.  The containers which are marked "Biohazard" shall be sealed before being removed from the laboratory.

(Source:  Added at 12 Ill. Reg. 9998, effective May 27, 1988)