PART450. ILLINOIS CLINICAL LABORATORIES CODE  


SUBPART A. GENERAL
§ 450.5. Scope and Applicability
§ 450.10. Definitions
§ 450.20. Permit and License Application
§ 450.30. Laboratories Covered
§ 450.35. Testing Limitations for Exempt, Permit and Licensed Laboratories
§ 450.40. Penalties and Fines
§ 450.50. Incorporated Materials
§ 450.60. Administrative Hearings
SUBPART B. DIRECTORS OF CLINICAL LABORATORIES
§ 450.210. Qualifications of the Director of a Clinical Laboratory
§ 450.220. Operational Participation of the Director
§ 450.230. Number of Laboratories Permitted to Operate
SUBPART C. LOCATION, CONSTRUCTION AND SANITATION
§ 450.310. Location
§ 450.320. Conformance to Local Ordinances
§ 450.330. Safety and Sanitation Manual
SUBPART D. QUALIFICATIONS OF PERSONNEL
§ 450.410. General Supervisor
§ 450.420. Medical Technologist
§ 450.430. Cytotechnologist
§ 450.440. Technician
§ 450.450. Laboratory Assistant
SUBPART E. EQUIPMENT
§ 450.510. Facilities and Equipment
§ 450.520. Preventive Maintenance of Equipment and Instruments
§ 450.530. Glassware [Repealed]
§ 450.540. Lancets, Needles and Syringes [Repealed]
§ 450.550. Electrical Equipment [Repealed]
§ 450.560. Photometric and Spectrophotometric Equipment [Repealed]
§ 450.570. Analytic Balances and Weights [Repealed]
SUBPART F. OUT OF STATE LABORATORIES
§ 450.610. Criteria for Licensure
SUBPART G. PROFICIENCY SURVEY PROGRAM AND INSPECTION OF FACILITIES
§ 450.710. Inspections
§ 450.720. Proficiency Survey Program
§ 450.730. Western Blot Assay Testing Procedures
SUBPART H. SPECIAL REQUIREMENTS PERTAINING TO BLOOD BANKS [Repealed]
§ 450.810. General [Repealed]
§ 450.820. Applicability of Other Parts of the Regulations [Repealed]
§ 450.830. Donors and Donor Blood/Criteria for Donor Selection [Repealed]
§ 450.835. Directed BLood Donations [Repealed]
§ 450.840. Donors and Donor Blood/Identification of Donor Blood [Repealed]
§ 450.845. Donors and Donor Blood/Storage and Transportation [Repealed]
§ 450.848. Preparation of Blood Components [Repealed]
§ 450.850. Plasmapheresis (or Plateletpheresis) [Repealed]
§ 450.860. Autologous Transfusion [Repealed]
§ 450.870. Transfusion Service Records [Repealed]
SUBPART I. PROHIBITED PRACTICE
§ 450.910. Prohibition Against Free Trial Tests [Repealed]
§ 450.920. Terms Not to be Used in Names of Laboratories
§ 450.930. Prohibitions in Advertising and Announcements
§ 450.940. Acceptance of Specimens and Reporting of Results
§ 450.950. Referral of Specimens for Examination to Unlicensed Laboratories
SUBPART J. RECORDS AND REPORTS
§ 450.1010. Necessary Records
SUBPART K. QUALITY CONTROL
§ 450.1110. Responsibilities of Director
§ 450.1120. Reference Materials
§ 450.1130. Preventative and Corrective Maintenance Program
§ 450.1140. Procedure Manuals
§ 450.1150. Quality Control System Methodologies
§ 450.1155. Cytology
SUBPART L. HIV CONTAMINATED BLOOD AND HUMAN TISSUE
§ 450.1200. Handling and Disposal of HIV Contaminated Blood and Human Tissue
SUBPART M. HEALTH SCREENING
§ 450.1300. Health Screening and Approved Health Screening Tests
§ 450.1310. Protocol for Conducting Health Screening
§ 450.1320. Application for a Class III Permit to Conduct Health Screening
§ 450.1330. Reporting and Notification
§ 450.APPENDIX A. Application for Registration, Class I Permit, Class II Permit, and Licensed Laboratory [Repealed]
§ 450.APPENDIX B. Application for Class III Permit Laboratory [Repealed]
§ 450.APPENDIX C. Exempt, Permit, and License Requirements – An Overview
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.

Notation

AUTHORITY: Implementing and authorized by the Illinois Clinical Laboratory Act (Ill. Rev. Stat. 1989, ch. 111 1/2, par. 621 et seq., as amended by P.A. 86-1292, effective September 6, 1990).