Section 470.10  Applicability

 

This Part applies to all facilities, institutions and entities which collect, procure, furnish, process, distribute, or store semen or tissue for the purpose of injecting, transfusing or transplanting these into any human body.

 

Section 470.20  Definitions

 

"Act" means Section 55.45 of the Civil Administrative Code of Illinois (Ill. Rev. Stat. 1987, ch. 127, par. 55.45).

 

"Department" means the Illinois Department of Public Health.

 

"Human Tissue" means an aggregation of morphologically and functionally similar cells including skin, organs, bone marrow, corneas, bones, muscle, oocytes (eggs), semen; except whole blood or its component parts. (Section 55.45(d) of the Act.)

 

"Legally Authorized Representative" means an individual who is authorized to consent to HIV testing and/or disclosure of HIV test results for an individual who is:

 

Under the age of twelve (12).

 

Deceased,

 

Declared incompetent by a court of law, or

 

Otherwise not competent to consent (for reasons other than age such as the apparent inability to understand or communicate with the health care provider) as determined by the health care provider seeking such consent.

 

The following individuals shall be authorized to consent, in the stated order of priority:

 

For a living or deceased child under the age of eighteen (18):

 

Parent, legal guardian or other court-appointed personal representative,

 

Adult next-of-kin

 

For a living or deceased adult age eighteen (18) or over:

 

Agent authorized by durable power of attorney for health care,

 

Legal guardian or other court-appointed personal representative,

 

Spouse,

 

Adult children,

 

Parent,

 

Adult next-of-kin.

 

"Sperm bank" means any facility or program such as a person, hospital, clinic, corporation, or partnership that is involved in procuring, furnishing, donating, processing, storing or distributing human semen for the purpose of artifical insemination.  (Section 55.45 (d) of the Act.)

 

"Test" or "HIV test" means a test to determine the presence of the antibody or antigen to HIV, or of HIV infection.

 

"Tissue bank" means any facility or program that is involved in procuring, furnishing, donating, processing, storing or distributing semen, corneas, bones, organs, or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body. (Section 55.45 (d) of the Act.)

 

Section 470.30  Registration Requirements

 

All Sperm Banks and Tissue Banks operating in this state shall register with the Department by May 1 of each year, by filing a written registration form in duplicate.  (Section 55.45 of the Act.)  The written registration of a Sperm Bank or Tissue Bank shall be on forms provided by the Department containing the following information:

 

a)         Name and address of the person, hospital, clinic, corporation, partnership or other legal entity which owns the sperm bank or tissue bank.

 

b)         Name and address of the person, hospital, clinic, corporation, partnership or other legal entity which operates the sperm bank or tissue bank, if different from the owner.

 

c)         A list of addresses and telephone numbers of all locations utilized in operating the sperm bank or tissue bank.

 

d)         An explanation of the operation and services provided by the sperm bank or tissue bank.

 

Section 470.40  Testing Requirements

 

a)         All donors of semen for purposes of artificial insemination, or donors of corneas, bones, organs, or other human tissue for the purpose of injecting, transfusing or transplanting any of them in the human body except for autologous injections, transfusions and transplantations, shall be tested by the potential donor's attending physician or by the Sperm Bank or Tissue Bank for evidence of exposure to human immunodeficiency virus (HIV) and any other identified causative agent of acquired immunodeficiency syndrome (AIDS) at the time of or after the donation, but prior to the semen, corneas, bones, organs, or other human tissue being made available for such use.

 

1)         All potential donors or Legally Authorized Representative shall receive the HIV pre-test information set forth in 77 Ill. Adm. Code 697.110(a) and be given the opportunity to refuse HIV testing.  However, the written informed consent provisions of 77 Ill. Adm. Code 697.120 are not required.

 

2)         If permission for HIV testing is not given, then the person shall not be accepted as a donor.

 

3)         The results of HIV testing shall be disclosed in accordance with the applicable provisions of 77 Ill. Adm. Code 250, 77 Ill. Adm. Code 450, 77 Ill. Adm. Code 460, 77 Ill. Adm. Code 697 and 77 Ill. Adm. Code 470.

 

4)         The results of HIV testing shall be kept confidential in accordance with the provisions of 77 Ill. Adm. Code 697.140.

 

5)         The donated semen, organs or other human tissue shall be disposed of in accordance with the provisions of Section 470.70 of this Part.

 

b)         When in the opinion of the attending physician the life of a recipient of a bone, organ or other human tissue donation would be jeopardized by delays caused by testing for evidence for exposure to HIV and any other causative agent of AIDS, testing shall not be required. (Section 55.45 (d) of the Act.)  The attending physician must provide this opinion in writing and a copy must be retained by the Tissue Bank for five years.

 

c)         Written informed consent is not required for a health care provider or health facility to perform a HIV test when the health care provider or health care facility procures, processes, stores, distributes or uses a human body part donated for a purpose specified under the Uniform Anatomical Gift Act, or semen provided prior to September 21, 1987 for the purpose of artificial insemination, and such a HIV test is necessary to assure medical acceptability of such gift or semen for the purposes intended.  (Section 7 of the AIDS Confidentiality Act, Ill. Rev. Stat. 1987, ch. 111½, par. 7307).

 

d)         The physician or Sperm Bank or Tissue Bank that performs the HIV testing shall confidentially inform the donor of the test results and provide whatever counseling or referral services are necessary.  (Section 7 of the AIDS Confidentiality Act, Ill. Rev. Stat. 1987, ch. 111½, par. 7307).

 

Section 470.50  Prohibitions Against Use

 

a)         No person may intentionally, knowingly, recklessly or negligently use the semen, corneas, bones, organs, or other human tissue of a donor unless the following conditions are met:

 

1)         The requirements of subsection (b) (Section 470.40 of this Part) have been met, and

 

2)         The semen, corneas, bones, organs, or other human tissue or donors of semen, corneas, bones, organs, oocytes (eggs) or other human tissue has not tested positive for exposure to HIV or any other identified causative agent of AIDS.

 

b)         Violation of this section shall be a Class 4 felony.  (Section 55.45 (d) of the Act.)

 

Section 470.60  Research Use

 

Any organs, semen or other human tissue showing exposure to HIV as evidenced by two of three reactive enzyme-linked immunosorbent assay (ELISA) test results (according to the package insert – product circular) on a blood sample from the donor or any other identified causative agent of AIDS or originating from a patient diagnosed with AIDS or ARC as defined in 77 Ill. Adm. Code 693.20, shall be disposed of in accordance with the provisions of Section 470.70 of this Part, unless a research facility licensed by the State requests, in writing, the use of such organs, semen, or other human tissue for AIDS research.  Any such semen or human tissue shall be disposed of in accordance with Section 470.70 when no longer being used for research purposes.

 

a)         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.).

 

b)         Any person delivering such organs, semen or other human tissue to research facilities pursuant to such a request shall file a report with the Department which shall include at least the following information:

 

1)         A copy of the request for semen or other human tissue;

 

2)         The quantity of semen or other human tissue delivered;

 

3)         The name and location of the research facility to which the semen or other human tissue was delivered; and

 

4)         The date and time of delivery.

 

Section 470.70  Disposal of Contaminated Semen and Human Tissue

 

All semen and human tissue showing exposure to HIV as evidenced by two of three reactive ELISA test results (according to the package insert – product circular) on a blood sample from the donor or any other identified causative agent of Acquired Immunodeficiency Syndrome (AIDS) or originating from an individual diagnosed with AIDS or AIDS-Realted Complex (ARC) as defined in 77 Ill. Adm. Code 693.20, shall be disposed of in accordance with the following requirements:

 

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

 

b)         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.)

 

c)         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.

 

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

 

1)         Incinerated or sterilized materials shall be disposed of through routine waste disposal methods with no precautions against possible contamination.

 

2)         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.)  These materials must be sealed, transported and stored in biohazard containers.

 

A)        These containers shall be marked "Biohazard", bear the universal biohazard symbol, and be orange, orange and black or red.

 

B)        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.

 

C)        The containers which are marked "Biohazard" shall be sealed before being removed from the Sperm Bank or Tissue Bank.

 

Section 470.80  Penalty

 

Any person, hospital, clinic, corporation, partnership or other legal entity which operates a Sperm Bank or Tissue Bank in this State and fails to register with the Department pursuant to this section commits a business offense and shall be subject to a fine of $5000.  (Section 55.54 of the Act.)