Section 475.10  Definitions

 

"Clinical Laboratory Improvement Amendments" or "CLIA" means federal regulations (Centers for Medicare and Medicaid Services, United States Department of Health and Human Services) (Laboratory Requirements; 42 CFR 493) (10/1/13) providing standards applicable to all facilities or sites in the United States that test human specimens for health assessment or to diagnose, prevent or treat disease.

 

"Department" means the Department of Public Health.

 

"Director" means the Director of the Department of Public Health.

 

"Laboratory" means the Division of Laboratories of the Illinois Department of Public Health, including its Chicago, Springfield and Carbondale Laboratories, and any other site designated by contract to perform Department Laboratory services.

 

"Person" means:

 

a medical provider;

 

the State, its agencies and departments, and its officers and employees;

 

any local health department and its officers and employees;

 

any grantee or contractor of the Department that agrees to provide services to the Department, or on behalf of the Department, and officers and employees of a grantee or contractor.

 

"Quality Control" means a procedure or set of procedures to assure the accuracy of results reported by the Laboratory.

 

"Supplemental Test" means any test approved by the United States Food and Drug Administration or validated under a laboratory's CLIA certification that is used to further characterize a specimen that had received a positive result when initially screened by the Laboratory.

 

(Source:  Amended at 38 Ill. Reg. 21494, effective October 31, 2014)

 

Section 475.12  Referenced Materials

 

a)         The following Illinois statutes and administrative rules are referenced in this Part:

 

1)         Civil Administrative Code of Illinois [20 ILCS 2310]

 

2)         Newborn Metabolic Screening and Treatment Code (77 Ill. Adm. Code 661)

 

3)         Lead Poisoning Prevention Code (77 Ill. Adm. Code 845)

 

4)         Control of Communicable Diseases Code (77 Ill. Adm. Code 690)

 

5)         Control of Tuberculosis Code (77 Ill. Adm. Code 696)

 

b)         The following federal statutes are referenced in this Part:

 

Health Insurance Portability and Accountability Act (HIPAA) (Public Law 104-191)

 

c)         The following federal regulations are incorporated by reference in this Part:

 

HIPAA Privacy Rules:  Access of Individuals to Protected Health Information (45 CFR 164.524) (2014)

 

d)         All incorporations by reference of federal regulations refer to the regulations or guidelines on the date specified and do not include any amendments or editions subsequent to the date specified.

 

(Source:  Amended at 38 Ill. Reg. 21494, effective October 31, 2014)

 

Section 475.15  Applicability

 

a)         This Part is applicable only to diagnostic laboratory tests.  This Part does not apply to reference laboratory tests performed free of charge by the Department, or to other laboratory analyses performed free of charge for either the Department or local health departments.

 

b)         This Part is not applicable to the Department's Laboratory screening of newborns for metabolic diseases under the Newborn Metabolic Screening and Treatment Code or to screening of children for elevated blood lead levels under the Lead Poisoning Prevention Code.  The fees established in this Part are in addition to other Laboratory fees established under separate statutory authority for two specific purposes: screening newborns for metabolic diseases under the Newborn Metabolic Screening and Treatment Code and screening children for elevated blood lead levels under the Lead Poisoning Prevention Code.

 

(Source:  Amended at 37 Ill. Reg. 6784_, effective ___________)

 

Section 475.17  Authorization to Submit Specimens or Samples

 

Each test performed by the Department of Public Health Division of Laboratories is in support of the Department of Public Health's mission to support public health programs by providing surveillance data. Testing services are authorized by local health departments or Department of Public Health programs.

 

a)         Authorization to obtain testing services is based on criteria including, but not limited to: the need for public health surveillance data with consideration of private testing availability; the need to characterize or identify an outbreak; prior approval from the Department or a local health department; or a submission that is required by the Control of Communicable Diseases Code or the Control of Tuberculosis Code.

 

b)         Authorization will be given for submission of clinical specimens if the submissions are part of a routine, ongoing surveillance program. Specimens that are not part of a routine, ongoing surveillance program will require specific authorization for each submission.  In those situations, medical providers shall discuss submission of the specimen with the relevant local health departments or Department of Public Health programs.

 

c)         Authorization will be given for continued submission of specified types of non-clinical samples if the submissions are part of a routine, ongoing surveillance program. Examples are water samples, food samples and rabies (animal) samples. Samples that are not part of a routine, ongoing surveillance program will require specific authorization for each submission.  In those situations, local health departments shall discuss submission of the sample with Department of Public Health programs.

 

d)         Samples or specimens submitted to the Laboratory without proper authorization will not be tested. Laboratory staff will contact the submitter and determine whether the sample/specimen will be returned or destroyed.

 

(Source:  Added at 38 Ill. Reg. 21494, effective October 31, 2014)

 

Section 475.20  Submission of Samples or Specimens

 

Each sample or specimen submitted to the Laboratory for any analysis shall be delivered or shipped in a container and manner to preserve the sample/specimen from contamination or destruction and to allow it to reach the Laboratory in a condition that permits a reliable laboratory analysis.

 

a)         The person submitting the sample/specimen shall deliver it to the Laboratory or send it in a package approved by the U.S. Postal Service or another commercial carrier for shipping. Any sample/specimen that is submitted in a package that violates the U.S. Postal Service's guidelines (or another commercial carrier's guidelines if an alternative carrier is used), is damaged in transit, is not received within the prescribed time frame for analysis, or is otherwise received in a condition that does not permit a reliable laboratory analysis, will be discarded.  When this occurs, the laboratory result will be reported as indeterminate or unsatisfactory, and the submitter will be notified so that another sample/specimen can be collected and submitted for analysis.

 

b)         For those laboratory services offered, the Laboratory will provide, upon request, sample/specimen collection materials or devices and mailing containers that meet the U.S. Postal Service regulations.

 

c)         Prior to delivering or shipping any sample/specimen to the Laboratory, the person submitting the sample/specimen shall confirm with the Laboratory the availability of the desired laboratory service/analysis and identify which Laboratory site or sites (e.g., Chicago, Springfield, Carbondale or a contract laboratory site) will perform the desired service/analysis and any testing authorization procedures that are required.  Samples/specimens shall be delivered or sent only to a specific Laboratory site designated as performing the requested laboratory service or to an alternative site agreed to in advance.

 

d)         The person submitting the sample/specimen shall pay for the postage or transport fee of the package unless alternative arrangements are made with the Laboratory in advance of mailing or shipping a sample/specimen to the Laboratory.

 

e)         Clinical specimens received by the Department will be retained for a minimum of one month.  If all test results obtained from a specimen are determined to be within normal range, the specimen will be retained for a maximum of four months.  If any test result obtained from a specimen is determined to be abnormal (i.e., out of normal range), the specimen may be retained for a maximum of six years.  Specimens that the Department retains may be used within the Department for quality control purposes as required under CLIA.  Based on the Department's testing capabilities, specimens with an abnormal result may be referred to other clinical laboratories for supplemental testing to further characterize the abnormality.  After the maximum time period for retention, the Department will destroy all specimens.

 

f)         Cultures, isolates and extracts of pathogens that are provided to the Department or result from testing samples/specimens that have been provided to the Department may be shared by the Department with other public health entities for quality assurance or method development purposes, provided that any and all patient identifiable information has been removed.

 

(Source:  Amended at 38 Ill. Reg. 21494, effective October 31, 2014)

 

Section 475.25  Fee Schedule

 

The Department has established fees for those diagnostic Laboratory services listed in subsection (b).

 

a)         The Laboratory's service fees, itemized in subsection (b), shall not exceed the Department's actual costs to provide the Laboratory's services, and shall consider the current fees charged by private laboratories for comparable services.  The Department's actual costs to perform the Laboratory's services shall include the costs of Laboratory personnel, materials and equipment; the Laboratory's data processing, quality control and support costs (e.g., facility-related costs, postage, telephones, supervision, etc.); any Laboratory marketing sales cost; and other Department costs outside the Laboratory but necessary to support the Laboratory's services (e.g., personnel and financial management costs).  The Laboratory's actual costs per unit of service are integrally dependent upon the current technology used to perform laboratory analyses, the test volumes for each laboratory service, and the unit cost of the materials or chemicals/reagents.  Because these actual costs per unit of service are subject to change, every effort will be made to review and update the Laboratory's fees on a regular (e.g., biennial) basis.

 

b)         Fees

Unless the sample or specimen is submitted as part of an agreed upon Department surveillance program, in which case the fee may be reduced, the fees for tests are:

 

Arbovirus Testing
St. Louis Encephalitis, West Nile Virus, California Encephalitis (Enzyme Immunoassay)	$73.31
St. Louis Encephalitis, West Nile Virus, California Encephalitis (Supplemental Test)	$100.22
Dengue Virus (Enzyme Immunoassay)	$73.31

 

Dairy Testing
Aflatoxin, Raw Milk	$214.31
Inhibitor (Beta-lactam)	$65.16
Petrifilm Aerobic Count	$134.81
Phosphatase	$64.66
Container Rinse Test	$74.60
Dairy Salmonella Test	$265.51
Total Coliform	$134.81
Dairy Water, Contained (Coliform)	$78.66
Dairy Water Well/Plant (Coliform)	$26.16

 

Food Testing
E. coli O157:H7	$355.12
Listeria monocytogenes	$261.11
Salmonella	$265.51
Shigella	$281.34
Total coliform	$134.81

 

Enteric Testing
Salmonella (Amplified Test)	$306.87
Salmonella (Serology)	$239.80
Shigella, E coli, Vibrio and Yersinia (Serology)	$239.80
Shigatoxin 1,2 (Amplified Test)	$86.70
Enteric PFGE (Pulse Field Gel Electrophoresis)	$342.33
Norovirus (Amplified Test)	$86.70

 

Lead Testing
Blood Lead	$26.33
Environmental Lead	$49.79

 

Parasite Testing
Malaria (Microscopic Observation)	$82.38
Malaria (Amplified Test)	$157.72
Cryptosporidium (Enzyme Immunoassay)	$78.01
Giardia (Enzyme Immunoassay)	$78.01
Cyclospora (Enzyme Immunoassay)	$78.01

 

Rabies Testing
Rabies	$232.78

 

Sexually Transmitted Infection Testing
Chlamydia trachomatis (Amplified Test)	$53.77
Neisseria gonorrhea (Amplified Test)	$53.77
Syphilis Serology (Enzyme Immunoassay)	$27.86
Syphilis Serology (Rapid Plasma Reagin)	$14.92
Syphilis Serology (Fluorescent Treponemal Antibody)	$39.54
HIV Serology 4th Generation (Chemiluminescent Microparticle Immunoassay)	$32.19
HIV Serology Differentiation (Enzyme Immunoassay)	$33.24
HIV Serology Supplemental (Amplified Test)	$86.70
HIV Oral Fluid (Western Blot)	$99.88
Herpes Simplex 1 & 2 (Amplified Test)	$86.70

 

Tuberculosis (TB) Testing
TB Acid Fast Bacillus, Smear	$33.14
TB (Culture)	$47.59
TB Drug Resistance	$114.81
TB (Amplified Test)	$142.72

 

Vaccine Preventable Disease Testing
Measles (Amplified Test)	$86.70
Mumps (Amplified Test)	$86.70
Pertussis (Amplified Test)	$86.70
Respiratory Virus Panel (Amplified Test)	$86.70

 

Water Testing
Bathing Beach E. coli (Microbiology)	$24.12
Private Water Well (Microbiology, Most Probable Number)	$26.16
Non-Community Public Water Supply (Microbiology, Presence/Absence)	$24.22
Nitrate-Nitrite (as Nitrogen)	$47.41

 

c)         Results of clinical laboratory tests will be provided to medical providers that submit a patient specimen.  A duplicate copy of a patient's test result will be provided upon written request by the medical provider that originally ordered the test.  Other medical providers will be provided a copy of patient test results upon the Department's receipt of proof of the patient's consent to release the patient's test result to that medical provider. 

 

d)         In accordance with the HIPAA Privacy Rules, upon receipt of a written notarized request by a patient or a patient's legal representative, the Department will provide a copy of the patient's clinical test result to the patient, patient's legal representative or persons designated by the patient or the patient's legal representative.  The request shall identify the patient, the patient's date of birth, and the test performed. The request shall be accompanied by a payment of $25.

 

e)         The Director may reduce any of the fees listed in subsection (b), pursuant to a written agreement executed prior to submission of the sample or specimen, between the Department and the person to be submitting the sample or specimen.  Examples of instances when reduced service fees may be considered include, but are not limited to, when the samples or specimens from, or test volumes for, one submitter will be very large; when a large one-time advance payment for all services is desired; and when the Department is participating in a special study requiring laboratory analysis.

 

f)         The Director may waive any of the standard laboratory fees prescribed in subsection (b) when the sample or specimen is submitted by Department staff (to support Department programs or services), another State agency, or any unit of local government, provided that the fee waiver is requested in writing and approved by the Director in writing prior to submission of the sample/specimen.

 

g)         The Director may enter into a written agreement with any commercial laboratory or governmental unit (contained within the definition of person) to provide additional laboratory services.  The agreement will specify any conditions established for the submission of samples or specimens and the fees for the services.

 

(Source:  Amended at 41 Ill. Reg. 10210, effective July 6, 2017)

 

Section 475.30  Statement of Fee Assessment

 

a)         Fees for Laboratory analyses shall be paid prior to services being provided, unless prior arrangements are made with the Department to bill the person submitting the sample/specimen.

 

b)         For persons with approval from the Department to submit samples/specimens without advance or accompanying payment, statements of fee assessment will be mailed or otherwise delivered to persons submitting samples for analysis monthly or quarterly as determined by the Director, depending on the number of samples or other circumstances unique to the testing.

 

c)         Receipt of statements of fee assessment will be presumed.

 

(Source:  Amended at 37 Ill. Reg. 6784, effective May 6, 2013)

 

Section 475.40  Payment of Fees

 

a)         Persons submitting samples for analysis shall either pay for the service in advance or submit the necessary fee with the sample/specimen, unless the submitter is a local health department or arrangements have been made with the Department to bill the submitter for the services.

 

b)         For local health departments and other persons that are approved to submit samples/specimens without advance or accompanying payment, the submitter shall render payment of fees assessed upon receipt of a statement of fee assessment.

 

(Source:  Amended at 20 Ill. Reg. 6958, effective May 5, 1996)

 

Section 475.50  Failure to Submit Payment

 

a)         Unless prior arrangements have been made with the Department to bill the submitter for Laboratory services rendered, the Laboratory may refuse to accept or may discard any sample/specimen that is not accompanied by the required service fee.

 

b)         For local health departments and other persons approved to submit samples/specimens without advance or accompanying payment, failure to submit full payment within two months after assessment shall be grounds for the Department to refuse future samples/specimens.

 

c)         The fee for a dishonored negotiable instrument, including, but not limited to, returned checks or insufficient payment, will be $35.

 

(Source:  Amended at 37 Ill. Reg. 6784, effective May 6, 2013)