TITLE 77: PUBLIC HEALTH CHAPTER I: DEPARTMENT OF PUBLIC HEALTH SUBCHAPTER d: LABORATORIES AND BLOOD BANKS PART 450 ILLINOIS CLINICAL LABORATORIES CODE The General Assembly's Illinois Administrative Code database includes only those rulemakings that have been permanently adopted. This menu will point out the Sections on which an emergency rule (valid for a maximum of 150 days, usually until replaced by a permanent rulemaking) exists. The emergency rulemaking is linked through the notation that follows the Section heading in the menu. View Entire Part SUBPART A: GENERAL Section 450.5 Scope and Applicability Section 450.10 Definitions Section 450.20 License Application Section 450.30 Laboratories Covered Section 450.35 Testing Limitations for Exempt, Permit and Licensed Laboratories (Repealed) Section 450.40 Penalties and Fines Section 450.50 Incorporated and Referenced Materials Section 450.60 Administrative Hearings SUBPART B: DIRECTORS OF CLINICAL LABORATORIES Section 450.210 Qualifications of the Director of a Clinical Laboratory Section 450.220 Operational Participation of the Director Section 450.230 Number of Laboratories Permitted to Operate SUBPART C: LOCATION, CONSTRUCTION AND SANITATION Section 450.310 Location Section 450.320 Conformance to Local Ordinances Section 450.330 Safety and Sanitation Manual SUBPART D: QUALIFICATIONS OF PERSONNEL Section 450.410 General Supervisor Section 450.420 Testing Personnel Section 450.430 Cytotechnologist (Repealed) Section 450.440 Technician (Repealed) Section 450.450 Laboratory Assistant (Repealed) Section 450.460 Technical Supervisor Section 450.470 Clinical Consultant SUBPART E: EQUIPMENT Section 450.510 Facilities and Equipment Section 450.520 Preventive Maintenance of Equipment and Instruments Section 450.530 Glassware (Repealed) Section 450.540 Lancets, Needles and Syringes (Repealed) Section 450.550 Electrical Equipment (Repealed) Section 450.560 Photometric and Spectrophotometric Equipment (Repealed) Section 450.570 Analytic Balances and Weights (Repealed) SUBPART F: OUT OF STATE LABORATORIES Section 450.610 Criteria for Licensure SUBPART G: PROFICIENCY SURVEY PROGRAM AND INSPECTION OF FACILITIES Section 450.710 Inspections Section 450.720 Proficiency Survey Program Section 450.730 Western Blot Assay Testing Procedures SUBPART H: SPECIAL REQUIREMENTS PERTAINING TO BLOOD BANKS Section 450.810 General Section 450.820 Applicability of Other Parts of the Regulations (Repealed) Section 450.830 Donors and Donor Blood/Criteria for Donor Selection (Repealed) Section 450.835 Directed BLood Donations (Repealed) Section 450.840 Donors and Donor Blood/Identification of Donor Blood (Repealed) Section 450.845 Donors and Donor Blood/Storage and Transportation (Repealed) Section 450.848 Preparation of Blood Components (Repealed) Section 450.850 Plasmapheresis (or Plateletpheresis) (Repealed) Section 450.860 Autologous Transfusion (Repealed) Section 450.870 Transfusion Service Records (Repealed) SUBPART I: PROHIBITED PRACTICE Section 450.910 Prohibition Against Free Trial Tests (Repealed) Section 450.920 Terms Not to be Used in Names of Laboratories Section 450.930 Prohibitions in Advertising and Announcements Section 450.940 Acceptance of Specimens and Reporting of Results Section 450.950 Referral of Specimens for Examination to Unlicensed Laboratories SUBPART J: RECORDS AND REPORTS Section 450.1010 Necessary Records SUBPART K: QUALITY CONTROL Section 450.1110 Responsibilities of Director Section 450.1120 Reference Materials Section 450.1130 Preventative and Corrective Maintenance Program Section 450.1140 Procedure Manuals Section 450.1150 Quality Control System Methodologies Section 450.1155 Cytology SUBPART L: HIV CONTAMINATED BLOOD AND HUMAN TISSUE Section 450.1200 Handling and Disposal of HIV Contaminated Blood and Human Tissue SUBPART M: HEALTH SCREENING Section 450.1300 Health Screening and Approved Health Screening Tests Section 450.1310 Protocol for Conducting Health Screening Section 450.1320 Application for a Class III Permit to Conduct Health Screening (Repealed) Section 450.1330 Reporting and Notification Section 450.APPENDIX A Application for Registration, Class I Permit, Class II Permit, and Licensed Laboratory (Repealed) Section 450.APPENDIX B Application for Class III Permit Laboratory (Repealed) Section 450.APPENDIX C Exempt, Permit, and License Requirements – An Overview (Repealed)

AUTHORITY: Implementing and authorized by the Illinois Clinical Laboratory and Blood Bank Act [210 ILCS 25].

SOURCE: Amended November 16, 1970; amended at 2 Ill. Reg., p. 87, effective November 5, 1978; amended at 4 Ill. Reg. 33, p. 224, 225 and 228, effective August 6, 1980; amended at 6 Ill. Reg. 4151, effective April 5, 1982; amended at 7 Ill. Reg. 7643, effective June 14, 1983; codified at 8 Ill. Reg. 19488; amended at 9 Ill. Reg. 20709, effective January 3, 1986; emergency amendment at 10 Ill. Reg. 307, effective January 3, 1986, for a maximum of 150 days; amended at 10 Ill. Reg. 10712, effective June 3, 1986; amended at 12 Ill. Reg. 10018, effective May 27, 1988; emergency amendment at 12 Ill. Reg. 19518, effective October 28, 1988, for a maximum of 150 days; amended at 13 Ill. Reg. 4285, effective March 21, 1989; amended at 13 Ill. Reg. 11573, effective July 1, 1989 and September 1, 1989; emergency amendment at 13 Ill. Reg. 13678, effective August 14, 1989, for a maximum of 150 days; emergency rule expired January 11, 1990; amended at 14 Ill. Reg. 2360, effective January 26, 1990; amended at 15 Ill. Reg. 15727, effective October 18, 1991; amended at 44 Ill. Reg. 20004, effective December 9, 2020.