Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 450 - ILLINOIS CLINICAL LABORATORIES CODE › Subpart M - HEALTH SCREENING › Section 450.1310 - Protocol for Conducting Health Screening

Current through Register Vol. 48, No. 28, July 12, 2024
a) Any entity that performs health screening
				shall establish a protocol for health screening activities that is
approved by a physician licensed to practice medicine in all its
				branches.
(Section 2-120(a) of the Act)
b) The protocol for conducting the health
				screening shall:
1) Indicate the tests to be
				conducted;
2) Indicate the way in
				which results shall be reported to the test subject , including any available
				oral counseling and health professional referral program;
3) Indicate how confidentiality will be
				maintained with provisions that allow testing personnel, test subject , and
				test subject's representative access to the test results;
4) Include a written quality control program
				to ensure accurate and precise test values as set by the physician signing the
				protocol and a description of the steps to be taken if the control values fall
				outside acceptable limits as set by the physician in the written quality
				control program;
5) Include the
				step -by -step instructions for the following:
A) Specimen collection, handling, transport,
				storage and disposal;
B) Patient
				preparation;
C) Type and volume of
				specimen needed and the established rejection criteria;
D) Proper specimen identification;
E) Proper reagent use, such as labeling,
				proper lot number usage, expiration dates, and storage requirements ;
				and
F) Instrument operation and
				calibration in accordance with the manufacturer's instructions ;
6) Include directions for the use
				of one reference material and one calibrator or two reference materials with
				different concentrations once each 24 hour period in which the analyzer is
				used;
7) Include a description of
				the training required of all staff conducting specific health screening
				tests;
8) Include a copy of
				educational materials for each individual screening test given to each test
				subject;
9) Be available to all
				health screening personnel at the test site;
10) Be sent to the Department at least 30
				days prior to the initial testing date if more than one health screening event
				is conducted by that entity in a calendar year. These protocols shall be
				effective for one year. An existing protocol may be renewed by submitting to
				the Department a letter from the physician who signed the protocol specifying
				that no changes have been made in the protocol and that the protocol will be
				used for health screenings over the next year. This letter shall be submitted
				within 30 days prior to the expiration of the existing protocol;
11) Be signed, dated, and approved by a
				physician licensed to practice medicine in all its branches no earlier than
				three months prior to submission date;
12) Include a copy of the document to be
				given to each test subject which discloses the purpose and limitations of each
				individual screening test to be conducted;
13) Include copies of any forms used in the
				course of conducting health screening activities;
14) Indicate how documentation and quality
				control items are traceable to each individual analyte and instruments used in
				the health screening process and how records shall be maintained; and
15) Indicate how records of test subject
				results and documentation of quality control items shall be maintained for two
				years .