TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER d: LABORATORIES AND BLOOD BANKS
PART 450 ILLINOIS CLINICAL LABORATORIES CODE
SECTION 450.1320 APPLICATION FOR A CLASS III PERMIT TO CONDUCT HEALTH SCREENING (REPEALED)


 

Section 450.1320  Application for a Class III Permit to Conduct Health Screening (Repealed)

 

The owner of a clinical laboratory which is operated and maintained exclusively for the purpose of conducting health screening tests by a person, corporation, organization, association or group which provides health screening services in accordance with Section 2-102.1 of the Act either directly or indirectly on a for-profit basis must obtain a permit from the Department.  Application shall be made on a form prescribed by the Department.  The application shall be accompanied by an application fee of $200 for each such permit.  The application shall be under oath (i.e. signed by the owner or authorized officer and notarized), the permit shall expire each year on a date specified on the permit, and the application shall contain the following information:

 

a)         The name and location of the owner's principal place of business;

 

b)         The name of the owner of such facility and of the director thereof;

 

c)         When the owner is a corporation the names and addresses of all persons owning five percent or more of shares of the corporation;

 

d)         a completed personnel form for the director(s), the anticipated schedule of hours for the director(s) to be at the laboratory during hours of testing, and other laboratories directed by the director(s);

 

e)         a description of the program and services provided by such clinical laboratory;

 

f)         The name of the laboratory assistant(s) or technician(s) employed and a completed personnel form for each laboratory assistant or technician;

 

g)         the name of the person(s) who is in charge of the total laboratory operation at the test site and a personnel form(s) for that person;

 

h)         a statement signed by the director indicating that the person in charge of the total laboratory operation at the test site has the education and training necessary to assure proper specimen collection, specimen handling, instrument operation, recordkeeping, reporting of results to assure confidentiality of test subjects and results, and proper sanitary conditions to protect the test subjects and environment;

 

i)          an explanation of the location where all equipment and supplies are kept when not at the test site and the location where all records are kept relating to the laboratory operations at the test sites; and

 

j)          a copy of the physician approved protocol.

 

(Source:  Repealed at 44 Ill. Reg. 20004, effective December 9, 2020)