Protocol For Conducting The Health Screening Events In The State Of Illinois Page 3

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Include a written quality control program to assure accurate and precise test values as recommended by

the test manufacturer (e.g., explain how you are going to make sure the testing instrument of choice is

operating as

described by the manufacturer - inferring to make sure that the instrument is operating as

expected and patient test results are reliable), and what steps will be taken if the test controls or test values

fall outside acceptable limits. ____________________________________________________________

____________________________________________________________________________________

Include a description of the training that will be provided to all employees participating or conducting the

listed specific health screening test(s) under question (1). ______________________________________

____________________________________________________________________________________

Indicate how records of test subject results and documentation of quality control items shall be

maintained for two years. _______________________________________________________________

____________________________________________________________________________________

Include copy of the test(s) reagent insert(s)/manufacturer’s instructions. (Attach to this document).

Include a copy of educational materials for each individual screening test (s) given to each test subject.

(Attach to this document).

Include a copy of the document to be given to each test subject that explains the purpose and limitations of each

individual CLIA Waived screening test. (Attach to this document).

10)

Include copies of any forms used in the course of conducting this health screening event.

(Attach to this document).

11)

Initial and changes in protocol must be sent to the Department at least 30 days prior to event testing date.

12)

Facilities with preapproved protocols must notify our office of any additional health screening event(s) no later

than 7 days.

13)

Protocols must be signed, dated and approved by a physician licensed to practice medicine in all its branches.

(Attach copy of physician Medical License).

_________________________________ _________________________________

Date ________________

Physicians Name (print)

Physicians Signature

Forms can be faxed to 217-782-0382, or mailed to IDPH CLIA Laboratory Certification Program, 525 W. Jefferson St., Fourth Floor, Springfield, IL 62761

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