ADMINISTRATIVE CODE

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER p: HAZARDOUS AND POISONOUS SUBSTANCES
PART 840 HEALTH AND HAZARDOUS SUBSTANCES REGISTRY CODE

SUBPART A: GENERAL REGISTRY PROVISIONS

Section 840.5 Purpose

Section 840.10 Definitions

Section 840.20 Incorporated and Referenced Materials

Section 840.30 Availability of Registry Information

Section 840.40 Administrative Hearings

Section 840.50 Quality Control

Section 840.60 Fee Assessment

SUBPART B: ILLINOIS STATE CANCER REGISTRY

Section 840.100 Entities Required to Submit Information

Section 840.110 Information Required to be Reported

Section 840.115 Methods of Reporting Cancer Registry Information

Section 840.120 Quality Control (Repealed)

SUBPART C: ADVERSE PREGNANCY OUTCOMES REPORTING SYSTEM

Section 840.200 Adverse Pregnancy Outcome

Section 840.210 Newborn Infant Case Reporting

Section 840.215 Methods of Reporting APORS Information (Repealed)

Section 840.220 Case Surveillance of Young Children

Section 840.230 Referral of APORS Cases

SUBPART D: OCCUPATIONAL DISEASE REGISTRY

Section 840.300 Entities Required to Submit Information

Section 840.305 Information Required to be Reported

Section 840.310 Methods of Reporting Occupational Disease

Section 840.APPENDIX A ISCR Incidence Report Form (Repealed)

Section 840.APPENDIX B Instructions for APORS Reporting (Repealed)

Section 840.APPENDIX C Forms and Instructions for Occupational Disease Registry (Repealed)

SUBPART A: GENERAL REGISTRY PROVISIONS

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER p: HAZARDOUS AND POISONOUS SUBSTANCES
PART 840 HEALTH AND HAZARDOUS SUBSTANCES REGISTRY CODE
SECTION 840.5 PURPOSE

Section 840.5 Purpose

a) It is the purpose of the Illinois Health and Hazardous Substances Registry Act [410 ILCS 525] to establish a unified Statewide project to collect, compile and correlate information on public health and hazardous substances. Such information is to be used to assist in the determination of public policy and to provide a source of information for the public. (Section 2(b) of the Act) The Registry shall consist of the compilation of information in the following categories:

1) Adverse pregnancy outcomes;

2) Cancer incidences;

3) Occupational diseases;

4) Location of, transportation of, and exposure to hazardous nuclear materials;

5) Company profiles; and

6) Hazardous substances incidents. (Section 6(a) of the Act)

b) The following subparts of this Part 840 apply to the different components of the Illinois Health and Hazardous Substances Registry: Subpart A: General Registry Provisions; Subpart B: Illinois State Cancer Registry: Subpart C: Adverse Pregnancy Outcome Reporting System and Subpart D: Occupational Disease Registry.

(Source: Amended at 31 Ill. Reg. 12207, effective August 2, 2007)

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER p: HAZARDOUS AND POISONOUS SUBSTANCES
PART 840 HEALTH AND HAZARDOUS SUBSTANCES REGISTRY CODE
SECTION 840.10 DEFINITIONS

Section 840.10 Definitions

"Act" means the Illinois Health and Hazardous Substances Registry Act [410 ILCS 525].

"Adverse pregnancy outcomes" includes but is not limited to birth defects, fetal loss, infant mortality, low birth weight, selected life-threatening conditions, and other developmental disabilities as defined in Section 840.200 of this Part. (Section 3(1) of the Act)

"Adverse Pregnancy Outcomes Reporting System" or "APORS" means the Illinois Department of Public Health program established to compile a registry of adverse pregnancy outcomes.

"Ambulatory Surgical Treatment Center" means any facility subject to licensure pursuant to the Ambulatory Surgical Treatment Center Act [210 ILCS 5].

"Birth center" means a facility as defined under the Alternative Health Care Delivery Act and licensed by the Department under the Birth Center Demonstration Program Code (77 Ill. Adm. Code 265) to provide birth services.

"Birth defect" means a condition of abnormal development related to body structure, body function, body metabolism, or an error of body chemistry that typically is identified at birth but can be diagnosed during pregnancy or following birth. Birth defects can originate in a number of ways, including having a genetic or metabolic origin.

"Cancer" means all malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma and leukemia. (Section 3(e) of the Act)

"Cancer-confirming report" means the simple biopsy, excision biopsy or surgical pathology report that confirms the morphologic (histologic) type of cancer, primary site, and the stage or extent of disease.

"Cancer incidence" means a medical diagnosis of cancer, consisting of a record of cases of cancer and specified cases of tumorous or precancerous diseases which occur in Illinois, and such other information concerning these cases as the Department deems necessary or appropriate in order to conduct thorough and complete epidemiological surveys of cancer and cancer-related diseases in Illinois. (Section 3(f) of the Act) Other information concerning cancer incidence may include, but is not limited to, diagnosis, staging, treatment, follow-up and survival information.

"Cancer surveillance" means the ongoing and systematic collection and analysis of information on new cancer cases, cancer deaths, extent of disease at diagnosis, treatment, clinical management, and survival.

"Clinical laboratory" means any clinical laboratory as defined in the Illinois Clinical Laboratory and Blood Bank Act [210 ILCS 25].

"Company profile" includes but is not limited to the name of any company operating in the State of Illinois which generates, uses, disposes of or transports hazardous substances, identification of the types of permits issued in such company's name relating to transactions involving hazardous substances, inventory of hazardous substances handled by the company, and the manner in which the hazardous substances are used, disposed of, or transported by the company. (Section 3(j) of the Act)

"Confidential data" means Health and Hazardous Substances Registry data containing identifiers or variables that, alone or in combination, can lead to identification of individuals, health care providers, or facilities (see Section 840.30(h)).

"Congenital" means present at birth, referring to certain mental or physical traits, anomalies, malformations, diseases, etc., that may be either hereditary or caused by an influence occurring during fetal development or pregnancy, up to the moment of birth.

"Council" means the Health and Hazardous Substances Coordinating Council created by the Act. (Section 3(c) of the Act)

"Current Procedural Terminology" or "CPT" or "Coding Index Version 2007" means the coding index developed by the American Medical Association (see Section 840.115).

"Death certificate clearance" means the process by which incident cases are added to the database through review of the cause of death on death certificates and subsequent follow-up with medical providers.

"Department" means the Illinois Department of Public Health. (Section 3(a) of the Act)

"DHS" means the Illinois Department of Human Services.

"Director" means the Director of the Illinois Department of Public Health. (Section 3(b) of the Act)

"DSCC" means the University of Illinois at Chicago's Division of Specialized Care for Children.

"Elevated blood lead level" means a concentration of lead in whole blood equal to or in excess of 10 micrograms per deciliter.

"Ethnicity" means the group of human kind to which an individual belongs, either Hispanic (Latino) or not Hispanic (not Latino).

"Facility" means a hospital, clinical laboratory, ambulatory surgical treatment center, independent radiation therapy center, independent pathology laboratory, reference pathology laboratory, nursing home, physician's office, other health care provider's office, and/or any other diagnostic or treatment center or other entity that is required by this Part to make reports to the Department. "Facility" also includes any other institution, place or building devoted primarily to the performance of medical care or surgical procedures that is maintained by the State or local government bodies.

"Facility-identifying information" means any information, collection or grouping of data from which the identity of the facility to which it relates may be discerned, e.g., name, address or Department-assigned facility identification number.

"Fetal death" means the demise of a fetus at gestation greater than 20 weeks; the death is indicated if the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles at delivery.

"Follow-up" means the reporting of or Registry-initiated obtainment of patient's survival information after the first diagnosis of the medical conditions defined by the Registry.

"Follow-up services" means medical, educational, social and family support services provided to infants and children with adverse pregnancy outcomes.

"Hazardous nuclear material" means:

any source or special nuclear material intended for use or used as an energy source in a production or utilization facility as defined in Sec. 11.v. or 11.cc. of the Federal Atomic Energy Act of 1954 as amended;

any fuel which has been discharged from such a facility following irradiation, the constituent elements of which have not been separated by reprocessing; or

any by-product material resulting from operation of such a facility. (Section 3(k) of the Act)

"Hazardous substances" means a hazardous substance as defined in Section 3.215 of the Environmental Protection Act [415 ILCS 5]. (Section 3(h) of the Act)

"Hazardous substances incident" includes but is not limited to spill, fire or accident involving hazardous substances, illegal disposal, transportation, or use of hazardous substances, and complaints or permit violations involving hazardous substances. (Section 3(i) of the Act)

"Hospital" means any facility subject to licensure pursuant to the Hospital Licensing Act [210 ILCS 85].

"Institutional review board" or "IRB" means a specially constituted review body established or designated by an institution to protect the welfare of human subjects participating in research.

"Lead hazard" means a lead-bearing substance that, because of its accessibility, poses a health hazard to humans.

"Local health authority" means the full-time official health department or board of health, as recognized by the Department, that has jurisdiction over a particular geographical area.

"mcg/d1" means micrograms per deciliter.

"Morphology" means a concise diagnostic description of a tumor that includes the kind of tumor, the behavior of the tumor (e.g., benign, in-situ, malignant, or malignant uncertain, whether primary or metastatic), and the grade or degree of differentiation of the cells.

"National Birth Defects Prevention Network" means a national organization dedicated to improving the quality of birth defect surveillance and providing technical assistance for the development of uniform methods of data collection.

"Neonatal" means related to the period immediately succeeding birth and continuing through the first 28 days of life.

"Newly diagnosed" means a condition or disease first discovered or diagnosed by a licensed physician, dentist, or other health care provider in a resident of the State of Illinois or a non-resident receiving medical diagnosis or treatment in the State of Illinois.

"North American Association of Central Cancer Registries" or "NAACCR" means the organization that sets standards that measure a central registry's data completeness, quality and timeliness.

"Occupational disease" includes but is not limited to all occupational diseases covered by the Workers' Occupational Diseases Act [820 ILCS 310]. (Section 3 (g) of the Act)

"Occupational Disease Registry" or "ODR" means the registry established under Section 6 of the Act to compile information on fatal and non-fatal occupational injuries, illnesses, and diseases.

"Other facility" means any person, organization, institution, corporation, partnership or other entity not required to be licensed as a health care facility by the State of Illinois, which maintains and operates facilities for the performance of diagnostic, laboratory or therapeutic services for the identification and treatment of cancer.

"Patient contact" means contacting patients based on collected Registry data.

"Patient-identifying information" means any information or collection or grouping of data from which the identity of the person to whom it relates may be discerned, e.g., name, address and social security number.

"Perinatal" means the period of time between the conception of an infant and the end of the first month of life. (Section 2(a) of the Developmental Disability Prevention Act)

"Perinatal center" means a referral facility intended to care for the high risk patient before, during or after labor and delivery and characterized by sophistication and availability of personnel, equipment, laboratory, transportation techniques, consultation and other support services. (Section 2(e) of the Developmental Disability Prevention Act)

"Prenatal" means preceding birth.

"Primary site" means the anatomic location in a cancer patient that identifies the site of origin of a tumor (i.e., where the cancer first began).

"Public health surveillance" means the ongoing systematic collection, analysis and interpretation of health data for purposes of improving health and safety.

"Race" means the major group of human kind to which an individual belongs, having distinct physical characteristics. These groups include, but are not limited to: American Indian or Alaska Native; Asian; Black or African American; Native Hawaiian or Other Pacific Islander; and White.

"Rapid case ascertainment" means special case-finding procedures that require early or preliminary reporting of certain types of cancer cases or adverse pregnancy outcomes. The procedure may include the review of patient medical records, pathology report forms, radiology reports, laboratory reports and other diagnostic tests.

"Record uniqueness" means the quantification of the risk of a breach of confidentiality of electronic health databases, including the identifiability of cases through triangulation of information or linkage with other electronic databases.

"Regional Perinatal Network" means any number and combination of hospitals providing maternity and newborn services at a designated level of perinatal care.

"Registry" means the Illinois Health and Hazardous Substances Registry established by the Department of Public Health under Section 6 of the Act. (Section 3(d) of the Act)

"Work" means duties, activities or tasks that produce a product or result; that are done in exchange for money, goods, services, profit, benefit or as a volunteer; and that are legal activities in the United States.

"Work-related injury or illness" means an event or exposure in the work environment that caused or contributed to the condition or significantly aggravated a preexisting condition. Work-relatedness is presumed for injuries and illnesses resulting from events or exposures occurring in the workplace.

"Workplace fatality" means a fatality that occurs to an employee (working for pay, compensation, or profit) or volunteer (exposed to the same work hazards and performing the same duties or functions as paid employees) while engaged in a legal work activity, or present at the site of the incident as a requirement of his or her job. A work relationship exists if an event or exposure results in a fatal injury to a person on or off the employer's premises and the person was there to work; or if the event or exposure was related to the person's work or status as an employee.

"Workplace nonfatal injury or illness" means an occupational injury resulting from a work-related event or from exposure in the work environment. Injuries or illnesses are reported if they result in lost work time; if they require medical treatment (other than first aid); or if the worker experiences loss of consciousness, restriction of work activities or motion, or is transferred to another job.

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER p: HAZARDOUS AND POISONOUS SUBSTANCES
PART 840 HEALTH AND HAZARDOUS SUBSTANCES REGISTRY CODE
SECTION 840.20 INCORPORATED AND REFERENCED MATERIALS

Section 840.20 Incorporated and Referenced Materials

a) The following materials are referenced in this Part:

1) State of Illinois Statutes

A) Illinois Health and Hazardous Substances Registry Act [410 ILCS 525]

B) Developmental Disability Prevention Act [410 ILCS 250]

C) Section 2310-365 of the Civil Administrative Code of Illinois [20 ILCS 2310/2310-365]

D) Lead Poisoning Prevention Act [410 ILCS 45]

E) Ambulatory Surgical Treatment Center Act [210 ILCS 5]

F) Illinois Clinical Laboratory and Blood Bank Act [210 ILCS 25]

G) Hospital Licensing Act [210 ILCS 85]

H) Freedom of Information Act [5 ILCS 140]

I) Part 21 of Article 8 of the Code of Civil Procedure, commonly known as the Medical Studies Act [735 ILCS 5/Art. 8, Part 21]

J) State Records Act [5 ILCS 160]

K) Vital Records Act [410 ILCS 535]

L) Environmental Protection Act [415 ILCS 5]

M) Workers' Occupational Diseases Act [820 ILCS 310]

N) Alternative Health Care Delivery Act [210 ILCS 3]

2) State of Illinois Rules:

A) Freedom of Information Code (2 Ill. Adm. Code 1126)

B) Practice and Procedure in Administrative Hearings (77 Ill. Adm. Code 100)

C) Hospital Licensing Requirements (77 Ill. Adm. Code 250)

D) Regionalized Perinatal Health Care Code (77 Ill. Adm. Code 640)

E) Birth Center Demonstration Program Code (77 Ill. Adm. Code 265)

3) Federal Statutes

A) Occupational Safety and Health Act of 1970 [29 USC 15]

B) The Birth Defects Prevention Act of 1998 [42 USC 201]

C) Public Health Service Act [42 USC 247b-4]

D) Federal Atomic Energy Act of 1954 [42 USC 2011]

b) The following materials are incorporated by reference in this Part:

1) Federal Regulations

A) Protection of Identity − Research Subjects, 42 CFR 2a.4(a) through (j), 2a.6(a) and (b) and 2a.7(a) through (b)(1) (October 1, 2009)

B) Occupational Safety and Health Standards, 29 CFR 1910.1025 (July 1, 2009)

2) Other Guidelines and Materials

A) International Classification of Diseases, 9^th Revision Clinical Modification (1986), World Health Organization, Avenue Appia 20, 1211 Geneva ZT, Geneva, Switzerland

B) International Classification of Diseases for Oncology (ICD-O), Third Edition (2000), World Health Organization, Avenue Appia 20, 1211 Geneva ZT, Geneva, Switzerland

C) International Classification of Diseases, 10^th Revision (1992), World Health Organization, Avenue Appia 20, 1211 Geneva ZT, Geneva, Switzerland

D) NAACCR Standards for Cancer Registries, Volume II, Data Standards and Data Dictionary, 19^th Edition, October 2014 (effective January 2015), North American Association for Central Cancer Registries, 2050 W. Iles Ave., Suite A, Springfield IL 62704

E) NAACCR Standards for Cancer Registries, Volume III, Standards for Completeness, Quality, Analysis, Management, Security, and Confidentiality of Data, August 2008, North American Association of Central Cancer Registries, 2050 W. Iles Ave., Suite A, Springfield IL 62704

F) NAACCR Standards for Cancer Registries, Volume V, Pathology Laboratory Electronic Reporting, Version 4.0, April 2011, North American Association of Central Cancer Registries, 2050 W. Iles Ave., Suite A, Springfield IL 62704

G) Current Procedural Terminology (CPT) Coding Index, 2007 Version, American Medical Association, P.O. Box 930876, Atlanta GA 31193

H) National Birth Defects Prevention Network (NBDPN), Guidelines for Conducting Birth Defects Surveillance, June 2004, Sever, LE, ed., 1600 Clifton Rd., Atlanta GA 30333

I) NAACCR/NPCR Disk 7 of Fundamentals of Registry Operations: Data Collection and Coding: Race and Ethnicity Procedures for Central Registries, May 2005, North American Association of Central Cancer Registries, 2050 W. Iles Ave., Suite A, Springfield IL 62704

J) NAACCR Record Uniqueness Analysis Software Version 1.5, May 2004, North American Association of Central Cancer Registries, 2050 W. Iles Ave., Suite A, Springfield IL 62704

K) Public Health Reporting and National Notification for Elevated Blood Lead Levels, Position Statement 09-OH-02, June 2009, Council of State and Territorial Epidemiologists, 2872 Woodcock Blvd., Atlanta GA 30341

L) ICD-10-CM 2015: The Complete Official Codebook, American Medical Association, P.O. Box 930876, Atlanta GA 31193.

c) All incorporations by reference of federal regulations and the standards of nationally recognized organizations refer to the regulations and standards on the date specified and do not include any later amendments or editions.

(Source: Amended at 40 Ill. Reg. 13397, effective September 12, 2016)

Section 840.30 Availability of Registry Information

a) All reports issued by the Department that are aggregated or recorded to make it impossible to identify any patient or reporting health care provider or facility, including the annual report, shall be made available to the public pursuant to the Department's Freedom of Information Code and the Freedom of Information Act.

b) All requests by medical or epidemiologic researchers for confidential Registry data shall be submitted in writing to the Department. The request shall include a study protocol that contains: objectives of the research; rationale for the research, including scientific literature justifying the current proposal; overall study methods, including copies of study forms, questionnaires, and consent forms used by researchers to contact facilities, health care providers or study subjects; methods for documenting compliance with 42 CFR 2a.4(a)-(k), 2a.6(a)-(b), and 2a.7(a)-(b)(1); methods for processing data; storage and security measures taken to ensure confidentiality of patient-identifying information; time frame of the study; a description of the funding source of the study (e.g., federal contract); and the curriculum vitae of the principal investigator and collaborators. In addition, the research request shall include a copy of the current IRB approval from the researcher's institution, signed assurance forms for all parties participating in the project and a completed application for the Department's internal IRB review process.

c) All requests to conduct research and modifications to approved research proposals involving the use of data that include patient- or facility- identifying information shall be subject to a review by the Department before approval to determine compliance with the following conditions:

1) The request for patient- or facility-identifying information contains stated goals or objectives.

2) The request documents the feasibility of the study design in achieving the stated goals and objectives.

3) The request documents the need for the requested data or interventions to achieve the stated goals and objectives.

4) The requested data can be provided within the time frame set forth in the request.

5) The request documents that the researcher has qualifications relevant to the type of research being conducted.

6) The request includes conditions relevant to the patient's confidentiality rights and the need for the patient- or facility- identifying information. The Department will release only the patient- or facility-identifying information that is necessary for the research.

7) Appropriate exemptions, IRB approvals and waivers have been obtained.

8) The request documents the researcher's commitment to provide updated status reports.

d) Research Agreements

1) The Department will enter into research agreements for all approved research requests. The agreement shall specify the exact information that is being released and how it can be used in accordance with the conditions in subsection (c). In addition, the researcher shall include an assurance that:

A) Use of data is restricted to the specifications of the protocol;

B) Any data that may lead to the identity of any patient, research subject, health care provider, other person or facility are strictly privileged and confidential. The researcher shall agree to keep this data strictly confidential at all times;

C) All officers, agents and employees will keep all data strictly confidential; will communicate the requirements of this Section to all officers, agents and employees; will discipline all persons who may violate the requirements of this Section; and will notify the Department in writing within 48 hours after any violation of this Section becomes known to the researcher or officers, agents and employees of the institution, including full details of the violation and corrective actions to be taken;

D) All data provided by the Department pursuant to the agreement shall be used only for the purposes named in the agreement, and any other or additional use of the data will result in immediate termination of the agreement by the Department and the violation will be reported to federal authorities if HIPAA is applicable;

E) All data provided by the Department pursuant to the agreement are the sole property of the Department and shall not be copied, reproduced or re-released in any form or manner. If required by the Department, the researcher shall agree to return all data and all copies and reproductions of the data to the Department upon termination of the agreement.

2) Any departures from the approved protocol shall be submitted in writing and approved by the Department in accordance with subsection (c) prior to initiation. A researcher shall not release any patient- or facility-identifying information to a third party.

e) The Department will disclose individual patient- or facility- information to the reporting facility that originally supplied that information to the Department, upon written request of the facility.

f) The Department, by signed and reciprocating agreement, will disclose individual patient information concerning residents of another state to the registry in the individual's state of residence only if the recipient of the information is legally required to hold the information in confidence and provides protection from disclosure of patient-identifying information equivalent to the protection afforded by the Illinois law.

g) The patient-identifying information submitted to the Department by those entities required to submit information under the Act and this Part will be used in the course of medical study under Article 8 Part 21 of the Code of Civil Procedure. Therefore, this information is privileged from disclosure by Article 8 Part 21 of the Code of Civil Procedure.

h) The identity, or any group of facts that tends to lead to the identity, of any facility or of any person whose condition or treatment is submitted to the Illinois Health and Hazardous Substances Registry, or the parent or guardian of any individual, is confidential and shall not be open to public inspection or dissemination and is exempt from disclosure under Section 7 of the Freedom of Information Act. The following data elements, alone or in combination, are confidential, shall not be open to public inspection or dissemination, and are exempt from disclosure under Section 7 of the Freedom of Information Act: name, social security number, street address, email address, telephone number, fax number, medical record number, certificate/license number, reporting source (unless permitted by the reporting facility), age (unless aggregated for 5 or more years), ZIP code (unless aggregated for 5 or more years), and diagnosis date (unless aggregated for one or more years for the entire State or for 3 or more years for a single county). Data defined by geographic areas that are smaller than ZIP code, such as census tract or census block groups, are considered confidential, and the information shall not be available for disclosure, inspection or copying under the Freedom of Information Act or the State Records Act. Information for specific research purposes may be released in accordance with procedures established by the Department in this Section. (Section 4(d) of the Act)

i) Hospitals, laboratories, other facilities or physicians shall not be held liable for the release of information or confidential data in accordance with the Act. The Department shall protect any information made confidential or privileged under law. (Section 4(e) of the Act)

j) Every reporting facility shall provide the Department or entities authorized to represent the Department with access to information from all medical, pathological, and other pertinent records and logs related to reportable Registry information in order for the Department to conduct rapid case ascertainment; death certificate clearance; patient follow-up; or any other review that is required to ensure data completeness, quality, and timeliness. The mode of access and the time during which this access will be provided shall be by mutual agreement between the facility and the Department (see Section 10 of the Act).

k) Every reporting facility shall provide access to diagnostic, treatment, follow-up and survival information for patients with specific medical conditions identified through Department-approved research studies involving rapid case ascertainment. The mode of access and the time during which this access will be provided shall be by mutual agreement between the facility and the Department (see Section 10 of the Act).

l) The Department will release individual patient or facility APORS information obtained from each Regional Perinatal Network facility to the Regional Perinatal Network's Administrative Perinatal Center, upon written request of that Administrative Perinatal Center's Clinical Director. The patient-and facility-identifying information released to the Perinatal Center by the Department as required under this Part shall be used in the course of medical study under Article 8 Part 21 of the Code of Civil Procedure and is privileged from further disclosure. The Administrative Perinatal Center's request for APORS data shall clearly indicate the purpose for which the data will be used. The Department will release data only for internal quality control or medical study for the purpose of reducing morbidity or mortality, or for improving patient care. The Department will provide a copy of the original request and the data that are released to the hospital that originally reported the data.

m) The Department will release APORS summary and statistical reports containing information that identifies individual patients or individual hospitals to the hospital that reported the patient, to the Administrative Perinatal Center with which the hospital is affiliated, and to the local health agency designated by the Illinois Department of Human Services to provide follow-up services to patients. The reports may contain information provided by the referring hospital and information provided by the follow-up agency. Data provided under this Section that are specific to the patient and reporting facility are confidential and shall not be otherwise disclosed.

n) The Department will release ODR data for fatal and non-fatal occupational injuries in aggregate form, with a minimum of three incidents, that have been approved by the United States Department of Labor's Bureau of Labor Statistics (BLS). Data provided under this subsection that are specific to a patient or employer are confidential and shall not be disclosed unless requested by BLS. ODR will release an annual report that will include the aggregate data collected for that year on the Department's website.

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

Section 840.40 Administrative Hearings

All administrative hearings shall be conducted pursuant to Practice and Procedure in Administrative Hearings.

(Source: Amended at 36 Ill. Reg. 8379, effective May 18, 2012)

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER p: HAZARDOUS AND POISONOUS SUBSTANCES
PART 840 HEALTH AND HAZARDOUS SUBSTANCES REGISTRY CODE
SECTION 840.50 QUALITY CONTROL

Section 840.50 Quality Control

a) Reporting facilities, including hospitals, ambulatory surgical treatment centers, independent radiation therapy centers, independent pathology laboratories, nursing homes, reference pathology laboratories, physician's offices and/or any other diagnostic or treatment center, shall be subject to review at least, but not limited to, once each year for the purpose of assessing the timeliness, quality and completeness of reporting by the facility. The review consists of the following components:

1) The Department auditing the reporting facilities to determine if all newly diagnosed cases have been identified (case-finding audits);

2) The Department performing death certificate clearance to identify cases that may not have been reported;

3) The Department performing patient follow-up to determine the survival information;

4) The Department conducting rapid case ascertainment to track cases;

5) The Department re-abstracting a sample of a reporting facility's medical records to determine the accuracy of information previously submitted to the Registry; and

6) The reporting facilities abstracting a sample of standard medical records to determine the uniformity of data collection.

b) A reporting facility shall, upon request of the Department, supply missing information if known, provide additional medical information when needed or clarify information previously submitted to the Department.

(Source: Amended at 31 Ill. Reg. 12207, effective August 2, 2007)

TITLE 77: PUBLIC HEALTH
CHAPTER I: DEPARTMENT OF PUBLIC HEALTH
SUBCHAPTER p: HAZARDOUS AND POISONOUS SUBSTANCES
PART 840 HEALTH AND HAZARDOUS SUBSTANCES REGISTRY CODE
SECTION 840.60 FEE ASSESSMENT

Section 840.60 Fee Assessment

The Department will charge persons or organizations, other than local health departments, State agencies or other units of State government, including the Illinois General Assembly and staff, for requested summaries or analyses of data that are not included in any report, survey or compilation of data prepared by the Department.

a) All requests for summaries or analyses of data not included in any report, survey or compilation of data prepared by the Department shall be in writing and include a protocol that meets the requirements of Section 840.30(b) of this Part.

b) Fees shall be assessed based upon the following:

1) Cost of data processing and programming;

2) Cost of administrative and clerical processing;

3) Cost of supplies and materials, if any; and

4) Cost of postage.

c) Upon receipt of the written request, the Department will estimate the amount of the fee calculated in accordance with subsection (b) and will issue a statement of fee assessment to the requestor. Payment of 50 percent of the estimated fee shall be rendered prior to initiating the project requested. All payments are nonrefundable.

d) Full payment of the final assessed fee shall be rendered upon receipt of the final statement of fee assessment and prior to receipt of the requested data.

e) Failure to submit the full assessed fee within 60 days after the receipt of the final statement of fee assessment will be deemed a withdrawal of the request. The Department will refuse future requests from a requestor who has not paid assessed fees.

(Source: Amended at 36 Ill. Reg. 8379, effective May 18, 2012)

SUBPART B: ILLINOIS STATE CANCER REGISTRY

Section 840.100 Entities Required to Submit Information

a) The Department requires the following facilities to report patient cancer incident information:

1) Hospitals;

2) Hospital-affiliated and free standing or independent laboratories;

3) Ambulatory Surgical Treatment Centers;

4) Independent Radiation Therapy Centers;

5) Independent and reference pathology laboratories;

6) Nursing homes;

7) Physicians' offices; and

8) Other Illinois facilities diagnosing and treating cancer.

b) The Department requests, but does not require, the following facilities to report cancer incidence information concerning present or past residents of Illinois:

1) Hospitals, clinical laboratories, ambulatory surgical treatment centers or clinics maintained by the federal government or agencies within the United States; and

2) Hospitals, clinical laboratories, ambulatory surgical treatment centers or clinics maintained by other states within the United States.

(Source: Amended at 31 Ill. Reg. 12207, effective August 2, 2007)

Section 840.110 Information Required to be Reported

a) A facility required to submit information shall report each cancer incidence and other tumorous and precancerous disease, as specified in this Section, to the Department.

b) This information to be reported shall be provided in a format as designated by the Department in electronic form. The electronic form must comply with the required standard. The facility tumor registrar or other person designated by the facility shall abstract information from the cancer patient's record. The information to be reported is divided into seven subject areas, each containing a particular set of information. The seven subject areas of the incidence report shall include the following:

1) Reporting Information – type of report being submitted, abstracter identification code and the date the abstract was submitted.

2) Patient Data and Resident Address − patient's full name (including maiden name, when applicable and available), Social Security number, telephone number, and residential address, including street address, city, county, state, and postal code.

3) Personal Data − patient's birthdate, age, sex, race, ethnicity, marital status, birthplace, history of tobacco and alcohol usage, history of occupation and industry, health insurance status and socio-economic status including, but not limited to, education and income.

4) Diagnosis Data − initial diagnosis date; diagnostic information; method of diagnosis; primary site; laterality; histology and behavior code; grade; stage of disease, including clinical and pathological extent of disease information; existence of other reportable primary diseases and date of diagnosis; first course cancer-directed therapy; and supporting text information for all diagnostic procedures, histology, primary site, staging and treatment.

5) Facility Data − facility identification number provided by the Department of Public Health, the medical record number, date of admission, type of reporting source, accession number (if available), case identification type, discharge date and status, class of case, and name and Illinois medical license number of attending physician.

6) Follow-Up Data − date of last follow-up or death, follow-up status, type of follow-up, names of follow-up physicians, cause of death, whether patient information is incomplete, and names and Illinois medical license numbers of managing and treating physicians.

7) Text Documentation – description of the primary site, histology, diagnostic test results, staging, pathology results and treatment information.

c) Each patient's cancer report form shall be sent within six months after the date of diagnosis or within four months after the date of discharge from the reporting facility, whichever is sooner. Reporting facilities shall report by letter to the Department, each year by July 1, the status of the completeness of reporting of cancer incidence cases diagnosed through December of the preceding year.

d) Every hospital, clinical laboratory, ambulatory surgical treatment center, independent radiation therapy center, independent pathology laboratory, reference pathology laboratory, nursing home, physician's office and other diagnostic or treatment facility shall provide the Department or entities authorized to represent the Department with access to information from all medical, pathological, and other pertinent records and logs related to cancer diagnosis, treatment and follow-up for the purpose of quality control, rapid case ascertainment, patient follow-up and death certificate clearance. (See Section 10 of the Act.)

e) Every hospital, ambulatory surgical treatment center, clinical laboratory, independent radiation therapy center, independent pathology laboratory, reference pathology laboratory, nursing home, physician's office and other diagnostic or treatment facility shall provide access to information from all medical, pathological, and other pertinent records and logs related to cancer diagnosis and treatment for the purpose of patient record review specified for research studies or for rapid case ascertainment related to cancer prevention and control conducted by the Department and that have been approved after appropriate review by the Department for assuring protection of human subjects. (See 42 CFR 2a.4(a)-(j), 2a.6(a)-(b), 2a.7(a)-(b)(1).)

(Source: Amended at 40 Ill. Reg. 13397, effective September 12, 2016)

Section 840.115 Methods of Reporting Cancer Registry Information

a) All patients identified at a reporting facility, whether as an inpatient or outpatient, who meet one of the three following criteria are reportable to the Registry:

1) Patients with a newly diagnosed cancer who have, within six months after diagnosis, received cancer-directed treatment or refused treatment.

2) Patient with cancer diagnosed through autopsy.

3) Patient diagnosed and receiving all first course treatment elsewhere and now receiving cancer-directed treatment at the reporting facility.

b) A patient is considered to have a malignant neoplasm when a licensed physician or dentist indicates that he/she does. Otherwise, the following terminology, when applied to a malignancy, shall be interpreted as indicating involvement by a cancerous tumor:

1) apparent,

2) appears to,

3) comparable with,

4) compatible with,

5) consistent with,

6) favors,

7) malignant appearing,

8) most likely,

9) presumed,

10) probable,

11) suspected,

12) suspicious for, and

13) typical of.

c) The following terminology, when applied to a malignancy without additional information, shall be interpreted as indicating non-involvement by a cancerous tumor:

1) cannot be ruled out,

2) equivocal,

3) possible,

4) potentially malignant,

5) questionable,

6) rule out,

7) suggests, and

8) worrisome.

d) Determination of whether or not a given primary tumor is reportable shall be made by reference to the morphology codes (M-codes) of the International Classification of Diseases for Oncology (ICD-O).

e) The specified cases of tumorous or precancerous diseases that shall be reported to the Registry are:

1) benign intracranial tumors, and

2) other conditions that the facility wishes to report.

f) Cases of basal or squamous cell neoplasms of the skin shall be reported only when located in the following areas: penis, scrotum, anus, eyelid, and muco-cutaneous junctions of the lips, labia and vulva.

g) Facilities shall electronically submit the report in the NAACCR data exchange format, using the version specified by the Registry (see Section 840.20). Supporting text documentation that is sufficient to support the diagnosis, stage and treatment should be included for each case submitted.

h) All reporting facilities are responsible for complete casefinding, which means identifying all first time reported cancer patients and completing an incidence report form for the Registry. To achieve complete case ascertainment, the following sources should be reviewed as they apply: Medical Record Disease Index (ICD-CM) or CPT Coding Index; pathology reports; cytology reports; autopsy reports; surgery and/or outpatient logs; radiation therapy and/or oncology clinic logs and appointment books; and diagnostic X-rays, nuclear medicine reports, and/or other imaging techniques.

1) Any patient's clinical record identified with any of the following ICD-9-CM Diagnosis, ICD-10-CM Diagnosis, or Procedure Codes by the Medical Record Department shall be reviewed for reportability to the Registry:

Diagnosis Codes Diagnosis (in preferred ICD-O-3 terminology)

A) 042 AIDS with malignancy

B) 140.0-208.9 Malignant neoplasms

C) 203.1 Plasma cell leukemia (9733/3)

D) 205.1 Chronic neutrophilic leukemia (9963/3)

E) 225.0-225.4 Benign intracranial and CNS neoplasms

225.8-225.9

227.3-227.4

F) 230.0-234.9 Carcinoma in situ

G) 237.0-237.1 Borderline intracranial and CNS neoplasms

237.5-237.6

237.7, 237.9

H) 238.4 Polycythermia erra (9950/3)

I) 238.6 Solitary plasmacytoma (9731/3)

J) 238.6 Extramedullary plasmacytoma (9734/3)

K) 238.7 Chronic Myeloproliferative disease (9960/3)

L) 238.7 Myelosclerosis with myeloid metaplasia (9961.3)

M) 238.7 Essential thrombocythemia (9962/3)

N) 238.7 Refractory cytopenia with multilineage displasia (9985/3)

O) 238.7 Myelodisplastic syndrome with 5q-syndrome (9986/3)

P) 238.7 Therapy related myelodisplastic syndrome (9987/3)

Q) 239.0-239.9 Neoplasms of unspecified behavior

R) 273.2 Gamma heavy chain disease; Franklin's disease

S) 273.3 Waldenstrom's macroglobulinemia

T) 273.9 Unspecified disorder of plasma protein metabolism (screen for potential 273.3 miscodes)

U) 284.9 Refractory anemia (9980/3)

V) 285.0 Refractory anemia with ringed sideroblasts (9982/3)

W) 285.0 Refractory anemia with excess blasts (9983/3)

X) 285.0 Refractory anemia with excess blasts in transformation (9984/3)

Y) 288.3 Hypereosinophilic syndrome (9964/3)

Z) 289.8 Acute myelofibrosis (9932/3)

AA) V07.8 Other prophylactic chemotherapy (screen carefully for miscoded malignancies)

BB) V07.8 Other specified prophylactic measures

CC) V10.0-V10.9 Personal history of malignant neoplasm (review these for recurrences, subsequent primaries and/or subsequent treatment)

DD) V58.0 Admission for radiotherapy

EE) V58.1 Admission for chemotherapy

FF) V66.1 Convalescence following radiotherapy

GG) V66.2 Convalescence following chemotherapy

HH) V67.1 Radiation therapy follow-up

II) V67.2 Chemotherapy follow-up

JJ) V71.1 Observation for suspected malignant neoplasm

KK) V76-V76.9 Special screening for malignant neoplasm

LL) 92.21-92.29 Therapeutic radiology and nuclear medicine

MM) 92.21-92.29 Injection or infusion of cancer

chemotherapeutic substance

NN) C00-C43, C45-C96 Malignant neoplasms (excluding category C44), stated or presumed to be primary (of specified site) and certain specified histologies. (Note: Pilocytic/juvenile astrocytoma (M-9421) is reported with the behavior coded /3 (i.e., 9421/3 not 9421/1).)

OO) D00-D09 In-situ neoplasms (Note: Carcinoma in situ of the cervix (CIN III-8077/2) and Prostatic Intraepithelial Carcinoma (PIN III-8148/2) are not reportable.)

PP) D18.02 Hemangioma of intracranial structures and any site

QQ) D18.1 Lymphangioma, any site (Note: Includes Lymphangiomas of Brain, Other parts of nervous system and endocrine glands, which are reportable.)

RR) D32 Benign neoplasm of meninges (cerebral, spinal and unspecified)

SS) D33 Benign neoplasm of brain and other parts of central nervous system (CNS)

TT) D35.2-D35.4 Benign neoplasm of pituitary gland, craniopharyngeal duct and pineal gland

UU) D42-D43 Neoplasm of uncertain or unknown behavior of meninges, brain, CNS

VV) D44.3-D44.5 Neoplasm of uncertain or unknown behavior of pituitary gland, craniopharyngeal duct and pineal gland

WW) D45 Polycythemia vera (9950/3)

XX) D46 Myelodysplastic syndromes

YY) D47.1 Chronic myeloproliferative disease

ZZ) D47.3 Essential (hemorrhagic) thrombocythemia (9962/3))

AAA) D47.4 Osteomyelofibrosis (9961/3)

BBB) D47.7 Other specified neoplasms of uncertain/unknown behavior of lymphoid, hematopoietic

CCC) D47.Z Other neoplasms of uncertain behavior of lymphoid, hematopoietic and related tissue

DDD) D47.9 Neoplasm of uncertain behavior of lymphoid, hematopoietic and related tissue unspecified

EEE) D49.6, D49.7 Neoplasm of unspecified behavior of brain, endocrine glands and other CNS

FFF) J91.0 Malignant pleural effusion

GGG) R18.0 Malignant ascites

HHH) Z08 Encounter for follow-up examination after completed treatment for malignant neoplasm

III) Z12 Encounter for screening for malignant neoplasms

JJJ) Z51.0 Encounter for antineoplastic radiation therapy

KKK) Z51.1 Encounter for antineoplastic chemotherapy and immunotherapy

LLL) Z85 Personal history of malignant neoplasm

MMM) Z86.0, Z86.01, Personal history of in situ and benign

Z86.03 neoplasms and neoplasms of uncertain behavior

NNN) Z92.21, Z92.23, Personal history of antineoplastic

Z92.25, Z92.3 chemotherapy, estrogen therapy, immunosuppression therapy or irradiation (radiation)

OOO) R85.614 Cytologic evidence of malignancy on smear of anus

PPP) R87.614 Cytologic evidence of malignancy on smear of cervix

QQQ) R87.624 Cytologic evidence of malignancy on smear of vagina

2) All pathology and cytology reports from the facility with a positive morphologic diagnosis of cancer shall be reviewed for reportable neoplasms, including reports on inpatient and outpatient surgical resections and biopsy specimens, bone marrow biopsies, cytology specimens and autopsies.

3) Any conflict of interpretation of cancer incidence shall defer to the clinician's determination.

i) All reporting facilities shall submit the report forms on a monthly basis.

(Source: Amended at 40 Ill. Reg. 13397, effective September 12, 2016)

Section 840.120 Quality Control (Repealed)

(Source: Repealed at 14 Ill. Reg. 5495, effective April 1, 1990)

SUBPART C: ADVERSE PREGNANCY OUTCOMES REPORTING SYSTEM

Section 840.200 Adverse Pregnancy Outcome

An adverse pregnancy outcome for an infant consists of one or more of the following case criterion:

a) A diagnosis of a birth defect, made prenatally or by two years of age;

b) A gestational age of less than 31 completed weeks (ICD-10-CM P07.21-P07.33);

c) A diagnosis of fetal alcohol syndrome (ICD-10-CM Q86.0);

d) A fetal or neonatal death;

e) Substance Use

1) Prenatal maternal, post-natal infant or post-natal maternal positive toxicology for any controlled substance (except drugs administered during labor and delivery);

2) a maternal admission to illicit drug use, or cannabis use during the pregnancy that led to the delivery of this infant; or

3) signs of drug toxicity or withdrawal; or

f) A diagnosis of one of the following conditions made prior to discharge from the newborn hospitalization:

1) Serious infections:

A) Prenatal exposure to syphilis (ICD-10-CM Z20.2) or a diagnosis of congenital syphilis (ICD-10-CM A50.01-A53.9);

B) Prenatal exposure to hepatitis B or hepatitis C (ICD-10-CM Z20.2) or a diagnosis of hepatitis B or hepatitis C (ICD-10-CM P35.3);

C) Prenatal exposure to chlamydia (ICD-10-CM Z20.2) or a diagnosis of a chlamydial infection ICD-10-CM A74.89, A74.9, or P23.1);

D) Prenatal exposure to herpes (ICD-10-CM Z20.2) or a diagnosis of congenital herpes (ICD-10-CM P35.2);

E) Group B streptococcus (ICD-10-CM J15.3 or P36.0);

F) Gonococcal conjunctivitis (neonatorum) (ICD-10-CM P39.1);

G) Congenital listeriosis (ICD-10-CM P37.2);

H) Congenital rubella (ICD-10-CM P35.0);

I) Congenital cytomegalovirus (ICD-10-CM P35.1);

J) Tetanus neonatorum (ICD-10-CM A33);

K) Septicemia of the newborn ICD-10-CM P36.0-P36.9);

L) Prenatal exposure to human immunodeficiency virus (ICD-10-CM Z20.6); or

M) Other congenital infections (ICD-10-CM P35.8, P35.9 or P37.0-P37.9).

2) Endocrine, metabolic or immune disorder:

A) Hypothyroidism (ICD-10-CM E03.0-E03.9);

B) Adrenogenital syndrome (ICD-10-CM E25.0-E25.9);

C) Inborn errors of metabolism (- ICD-10-CM E70.0-E79.9);

D) Cystic fibrosis (ICD-10-CM E84.0-E84.9); or

E) Immune deficiency disorder (ICD-10-CM D80.0-D81.9).

3) Blood disorder:

A) Leukemia (ICD-10-CM C91.0-C95.92);

B) Hereditary hemolytic anemias (ICD-10-CM D58.0-D58.9);

C) Constitutional aplastic anemia (ICD-10-CM D61.0-D61.09); or

D) Coagulation defects (ICD-10-CM D65-D68.9).

4) Other conditions:

A) Neurofibromatosis (ICD-10-CM Q85.0-Q85.9);

B) Cerebral lipidoses ICD-10-CM E75.4);

C) Retinopathy of prematurity (ICD-10-CM H35.1-H35.17);

D) Chorioretinitis (ICD-10-CM H30.00-H30.93);

E) Strabismus (ICD-10-CM H50.00-H50.9);

F) Endocardial fibroelastosis (ICD-10-CM I42.4);

G) Occlusion of cerebral arteries (ICD-10-CM I63.30-I63.59 or I66.0-I66.9);

H) Bronchopulmonary dysplasia (ICD-10-CM P27.1);

I) Intrauterine growth retardation ICD-10-CM P05.0-P05.9);

J) Intraventricular hemorrhage grade III (ICD-10-CM P52.21);

K) Intraventricular hemorrhage grade IV ICD-10-CM P52.22);

L) Seizures (ICD-10-CM P90);

M) Other conditions leading to more than 72 hours on a ventilator (ICD-10-CM Z99.11);

N) Conditions leading to extracorporeal membrane oxygenation (ECMO) (ICD-10-CM Z92.81)

O) Erb's Palsy (ICD-10-CM P14.0)

P) Hypoxic ischemic encephalopathy leading to cooling treatment (ICD-10-CM P91.63)

AGENCY NOTE: The products of induced abortions shall not be reported to APORS.

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

Section 840.210 Newborn Infant Case Reporting

a) Entities required to report newborn infant cases:

1) The Department requires all hospitals and birth centers licensed by the State of Illinois to report adverse pregnancy outcome information for cases identified during newborn infant hospitalization or care.

2) The Department requests, but does not require, hospitals outside Illinois and hospitals maintained by the federal government or other governmental agencies of the United States to report adverse pregnancy outcome information identified during the newborn hospital stay of infants whose mothers were Illinois residents at the time of delivery.

3) The Department requires clinical laboratories licensed by the State of Illinois to report newborn infants who have positive toxicology for controlled substances or cannabis and its metabolites.

4) The Department requires all hospitals and birth centers that are members of an Illinois Perinatal Network to report adverse pregnancy outcome information for cases identified during newborn infant hospitalization or care.

b) Reporting newborn infant cases by hospitals:

1) Every hospital shall develop procedures and policies for identifying newborn infants who meet an APORS case criterion (see Section 840.200) and shall report these newborn infants to APORS.

2) When a newborn infant meets a case criterion (see Section 840.200) and is transferred to another hospital for a higher level of care, the hospital providing the highest level of care shall report the case.

3) Hospitals are required to report newborn infant cases in the format provided by the Department.

A) The Department will provide the hospitals with written instructions for completing an APORS report.

B) Hospitals shall use the Department's format for APORS reports and shall report the following information:

i) Reporting hospital four-digit facility identification number, name and city and state if not Illinois;

ii) Delivery hospital four-digit facility identification number, name and city and state if not Illinois; for births that do not occur in a hospital, the location should be provided by address or by description;

iii) Infant's patient identification number;

iv) Date the infant was admitted to the reporting hospital;

v) Infant's date of birth;

vi) Infant's discharge date from the reporting hospital;

vii) Infant's first, middle and last names;

viii) Other names by which the infant may be known;

ix) Infant's sex;

x) Infant's race;

xi) Infant's ethnicity;

xii) Whether the infant was admitted to the Intensive Care Unit;

xiii) Whether the infant was exposed to drugs (except drugs administered during labor and delivery) prenatally and, if applicable, what type;

xiv) Birth mother's hepatitis B status;

xv) Dates infant's hepatitis B immunizations were provided, if applicable;

xvi) For infants with exposure to hepatitis B or with unknown maternal hepatitis B status, the times infant's hepatitis B immunizations were provided, and the type of vaccine given;

xvii) Infant's gestational age at delivery in weeks and days;

xviii) Infant's birth weight in grams;

xix) Infant's birth order;

xx) Pregnancy plurality;

xxi) Infant's medical record number;

xxii) Infant's diagnoses made prior to the newborn discharge;

xxiii) Birth mother's first, middle and last names;

xxiv) Birth mother's maiden name;

xxv) Birth mother's address at delivery, including number, direction, street name, type of street, apartment number, city, state and ZIP code;

xxvi) Birth mother's county of residence at delivery;

xxvii) Birth mother's medical record number;

xxviii) Birth mother's social security number;

xxix) Birth mother's date of birth;

xxx) Birth mother's telephone number, including the area code;

xxxi) Father's first, middle and last names;

xxxii) Father's date of birth;

xxxiii) Father's social security number;

xxxiv) Number of the birth mother's pregnancies, including the pregnancy resulting in this infant;

xxxv) Number of pregnancies that produced: full-term infants, premature infants, abortions (spontaneous and induced), currently living children;

xxxvi) Infant's status on discharge: deceased, going home with parents or other family member, transferring to another hospital, transferring to a long-term care facility, being adopted, going to foster care, or in Department of Children and Family Services (DCFS) custody;

xxxviii) Name, city and four-digit facility identification number of facility to which child was discharged, if applicable;

xxxviii) Name, address and telephone number (including area code) of the person to whom the infant was discharged if the infant did not go home with the birth mother;

xxxix) Delivery type, either vaginal or caesarean section;

xl) Feeding type, either breast, bottle or tube;

xli) If applicable, formula type, frequency and amount;

xlii) Infant's discharge weight in grams;

xliii) Infant's head circumference, in centimeters, at the time of birth;

xliv) Infant's head circumference, in centimeters, at the time of discharge, if discharged alive;

xlv) Infant's length, in centimeters, from crown to heel at the time of birth;

xlvi) Treatments prescribed for the infant at discharge;

xlvii) Medication name, dosage and route of administration prescribed for the infant at discharge;

xlviii) Other health, social and developmental concerns;

xlix) Name and telephone number (including area code) of registered nurse who can be contacted by the public health nurse making home visits to the infant;

l) Name, address and telephone number (including area code) of a relative, friend or other person who would know how to contact the infant's parents and the relationship of that person to the birth parents;

li) Whether the infant's family has been informed that a local public health nurse will contact them to offer follow-up services in their home after the infant is discharged from the hospital;

lii) Name and the four-digit identification code of the local health agency that serves families in the county or city where the infant will be located;

liii) Indication of whether the infant or the infant's family is receiving services from a community social service agency, Division of Specialized Care For Children (DSCC), DCFS, or other agency;

liv) Name of the infant's primary health care provider;

lv) Name and title of the person providing the information;

lvi) Date the report is completed.

4) Hospitals are required to fully complete all sections of the report and to send the report to the Department within seven days after the newborn infant's discharge or death.

5) When hospital-submitted reports are incomplete, the Department will contact the hospital within 30 days after receiving the report. The hospital shall supply the missing information to the Department within 30 days after receiving the request.

6) When a newborn infant is discharged, the hospital shall notify the infant's parents or legal guardian that the infant was reported to the Department and that the infant will be referred to health agencies for services.

7) Hospitals shall provide the parents or legal guardian with materials provided by DHS that explain the follow-up services that will be offered to the family.

8) Hospitals shall provide copies of the report submitted to the Department to the parents or legal guardian if requested. All other requests for copies shall be denied.

9) Hospitals shall distribute the original report and one copy in the following manner:

A) The original report shall be sent to the Department's Division of Epidemiologic Studies, 535 West Jefferson, 3^rd Floor, Springfield, Illinois 62761; and

B) One copy shall be sent to the infant's primary health care provider.

c) Reporting newborn infant cases by clinical laboratories:

1) Clinical laboratories are required to develop procedures and policies to report newborn infant cases of positive toxicology for controlled substances and cannabis. Negative results are not reported to the Department.

2) Clinical laboratories are required to submit:

A) Infant's name (first, middle and last);

B) Infant's date of birth;

C) Residential address, including street address, city, county, state and ZIP code;

D) Unique identification number assigned by the submitting facility;

E) Name of the facility submitting the test;

F) Address of the facility submitting the test;

G) Test results, including the type of substance found; and

H) Date of the test.

3) The clinical laboratory shall send the test results to the Department within seven days after the laboratory completes testing.

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

Section 840.215 Methods of Reporting APORS Information (Repealed)

(Source: Repealed at 31 Ill. Reg. 12207, effective August 2, 2007)

Section 840.220 Case Surveillance of Young Children

a) Facilities required to provide data:

1) Hospitals;

2) Prenatal and obstetric centers;

3) Specialty health clinics that treat or provide services to children with birth defects;

4) Genetics centers;

5) Laboratories, including cytogenetic, prenatal diagnostic and metabolic; and

6) Health care providers who provide prenatal or pediatric care or treat young children with a birth defect diagnosis.

b) Provision of data by cytogenetic laboratories and genetic clinics:

1) All cytogenetic laboratories and genetic clinics shall report abnormal cytogenetic test results for prenatal and postnatal testing. Negative results or normal results are not reported to the Department.

2) The cytogenetic laboratories and genetic clinics shall submit:

A) Patient's name (first and last);

B) Date of birth;

C) Residential address, if available, including street address, city, county, state and postal code;

D) Unique identification number assigned by the submitting facility or health care provider;

E) Name of the facility or health care provider submitting the test;

F) Address of the facility or health care provider submitting the test;

G) Test results; and

H) Date of the test; and

I) Type of test.

3) The test results shall be sent to the Department within seven days after the testing is complete.

c) Provision of data by other medical facilities:

1) Prenatal and obstetric centers; specialty health clinics that treat or provide services to children with birth defects; genetics centers; laboratories, including cytogenetic, prenatal diagnostic and metabolic; and health care providers who provide prenatal or pediatric care or treat young children who have birth defects shall provide data about prenatally diagnosed birth defects and birth defects in young children up to two years of age.

2) Upon the request of the Department, the facilities listed in subsections (a)(2)-(5) shall provide birth defects surveillance information to the Department.

d) Availability of information for birth defect surveillance of young children:

1) All facilities listed in subsection (a) shall make medical records of mothers and children having a case condition (see Section 840.200) or a risk factor for a case condition available to the Department. The medical records will be reviewed by APORS staff to ascertain birth defect cases and collect pertinent data.

2) The facilities shall make electronic medical records of children having a case condition diagnosis or a risk factor for a birth defect available to the Department through remote computer access.

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

Section 840.230 Referral of APORS Cases

Based on information reported pursuant to Section 840.210, infants diagnosed with the following conditions shall be referred for follow-up services and public health surveillance:

a) APORS staff will report infants diagnosed with the following craniofacial anomalies to the Department's Division of Oral Health, Craniofacial Anomaly Program, for referral to follow-up medical services:

1) Cleft lip;

3) Cleft palate; and

3) Cleft palate with cleft lip.

b) APORS staff will refer all infants meeting APORS reporting criteria (see Section 840.200) to the local health department or health agency in the county where the infant resides for services, except those with prenatal exposure to human immunodeficiency virus. The services provided by the local health department or health agency are not mandatory, and parents or legal guardians of the infant may decline follow-up services.

c) APORS staff will refer infants diagnosed with selected conditions to DSCC . DSCC will determine these conditions in consultation with APORS. Referrals will be made at an interval and in a format that is agreed upon by APORS and DSCC. The services offered by DSCC are not mandatory, and parents or legal guardians of the infant may decline follow-up services. The conditions will include, but are not limited to:

1) Newborn metabolic disorders;

2) Severe retinopathy of prematurity;

3) Spina bifida;

4) Congenital hydrocephalus;

5) Cataracts;

6) Ear defects causing hearing impairment;

7) Transposition of the great vessels;

8) Tetralogy of Fallot;

9) Ventricular septal defects;

10) Heart valve atresia or stenosis;

11) Cleft lip or palate;

12) Clubfoot; and

13) Limb reduction defects.

d) APORS staff will refer infants diagnosed with selected conditions to the DHS Early Intervention Program. The Early Intervention Program will determine these conditions in consultation with APORS. Referrals will be made at an interval and in a format that is agreed upon by APORS and the Early Intervention Program. The services provided (or offered) by the Early Intervention Program are not mandatory, and parents or legal guardians of the infant may decline follow-up services. The conditions will include, but are not limited to:

1) Newborn metabolic disorders;

2) Retinopathy of prematurity;

3) Spina bifida;

4) Congenital hydrocephalus;

5) Brain anomalies;

6) Microphthalmos;

7) Cataract;

8) Cleft lip or palate; and

9) Trisomy 13, 18 or 21.

e) APORS staff will refer infants diagnosed with the following congenital infections to the Department's Division of Infectious Diseases within seven days after the information is entered into the APORS data system:

1) Prenatal exposure to syphilis or a diagnosis of congenital syphilis;

2) Prenatal exposure to hepatitis B;

3) Prenatal exposure to chlamydia or a diagnosis of a chlamydial infection;

4) Prenatal exposure to herpes or a diagnosis of congenital herpes;

5) Prenatal exposure to human immunodeficiency virus; or

6) Gonococcal conjunctivitis (neonatorum).

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

SUBPART D: OCCUPATIONAL DISEASE REGISTRY

Section 840.300 Entities Required to Submit Information

a) The Department requires the following facilities to report occupational disease incidence information:

1) Clinical laboratories and hospital laboratories registered, permitted or licensed by the State of Illinois for blood lead level testing and data collection. Clinical laboratories are required to submit:

A) Date of report, including month, day and year the report is completed, in the format mo/day/year, using two digits for month and day and four digits for year;

B) Last name of the case;

C) First name of the case;

D) Middle initial of the case;

E) Maiden name of the case, if applicable;

F) Complete address where the case resides on a permanent basis (refers to domicile, i.e., the address from which the case may lawfully register to vote if proper age is attained), including number, direction, street name, apartment number, type of street, city, state and ZIP code;

G) County where the case currently resides;

H) Telephone number of the case, including area code;

I) Date of birth of the case, using two digits for the month, two digits for the day and four digits for the year;

J) Gender: the appropriate number for the gender of the case, if available, as 1=male, 2=female, 3=other (includes persons with both male and female reproductive organs and persons who have undergone sex change) or 9=unknown;

K) Social security number of the case;

L) Name of submitting party, including the name of the person, industry, physician, hospital, laboratory, clinic or other facility submitting the blood lead sample to the laboratory to be analyzed;

M) Title, if applicable, of the person submitting the blood lead sample to the laboratory to be analyzed;

N) Telephone number of the submitting party (area code and seven digit number);

O) Submitting party type: as either physician, industry (employer), hospital, laboratory (private or public), clinic or other (e.g., nurse, other health care professional, judge);

P) Testing facility name: name of the laboratory analyzing the blood lead sample;

Q) Testing facility address: address of the laboratory analyzing the blood lead sample, including number, street name, direction and type of street, city, state and ZIP code;

R) Testing facility phone number, including area code;

S) Test results: blood lead level of the sample in micrograms per deciliter (mcg/dL);

T) Date of sample collection, using two digits for month and day and four digits for year;

U) Date of sample receipt by the laboratory, using two digits for month and day and four digits for year;

V) Date of sample analysis by the laboratory, using two digits for month and day and four digits for year;

W) Specimen type provided to the laboratory, as either venous, capillary or unknown;

X) Methodology used to analyze the blood lead sample, as either delves cup, extraction-atomic absorption spectrometry, carbon rod-atomic absorption spectrometry, graphite furnace-atomic absorption spectrometry, anodic stripping voltammetry, hematofluorometry or other.

2) Local health authorities and other facilities for blood lead level testing and data collection shall be required to provide information on cases of elevated blood lead levels as contracted by or upon request of the Department.

3) Physicians' offices or clinics shall be required to provide information on cases of elevated blood lead levels upon request of the Department.

b) The Department requests that clinical or hospital laboratories maintained by the federal government or other facilities within the United States report all incidence of the occupational disease being collected from the facility or from other data base sources to the Department. An agreement will be established between the Department and the facility for the purpose of collecting data on Illinois residents known to have the specified occupational disease determined by the Department to be reported or collected for the Registry. These facilities, hospitals or clinical laboratories include all those out-of-state certified by the Department or by the Occupational Safety and Health Administration (OSHA) to conduct elevated blood lead levels.

(Source: Amended at 36 Ill. Reg. 8379, effective May 18, 2012)

Section 840.305 Information Required to be Reported

a) The Occupational Disease Registry shall consist of information on the following occupational disease incidences:

1) Elevated blood lead levels (lead poisoning);

2) Workplace fatalities;

3) Workplace nonfatal injuries and illnesses; and

4) Other specific illnesses such as asbestosis, silicosis and coal worker's pneumoconiosis.

b) Information on the occupational disease incidences shall be collected in four ways.

1) Information concerning elevated blood lead levels (lead poisoning) shall be reported to the Department by the facilities specified in Section 840.300 of this Part.

A) The Department will follow up with attending physicians or patients/cases or will contract with the local health authorities that agree to conduct interviews with patients/cases, or attending physicians as needed, to assure the accuracy and completeness of reports. The Department or contracted local health authority will perform the activities or case follow-up for elevated blood lead levels equal to or in excess of 10 mcg/dl set forth in subsection (b)(1)(B).

B) The agreement with local health authorities will contain requirements for the performance of the following activities or patient follow-up:

i) Trace the patient or case;

ii) Counsel the patient or case;

iii) Educate the patient or case;

iv) Interview the patient or case for purposes of collecting, verifying or completing the information identified in subsection (b)(1) of this Section; and

v) Submit completed reports to the Department within 30 business days after receipt of the laboratory report for adult elevated blood lead analysis.

2) Information concerning fatal occupational injuries and illnesses shall be collected from various reporting sources, including, but not limited to, death certificates, newspaper clipping services, OSHA reports and coroner's reports.

3) Information concerning nonfatal occupational injuries and illnesses shall be collected using the U.S. Department of Labor, Bureau of Labor Statistics' Survey of Occupational Injuries and Illnesses, an annual sample survey of Illinois companies and governmental units.

4) Information concerning specific illnesses shall be collected from existing data sources such as the hospital discharge database or medical records.

c) Reports of elevated blood lead levels shall be reported by facilities to the Department by manual submission (paper) or by electronic submission.

d) All completed elevated blood lead level submissions are to be mailed to the Illinois Department of Public Health, Division of Epidemiologic Studies, Occupational Disease Registry, 535 West Jefferson Street, 3^rd floor, Springfield, Illinois 62761 or submitted electronically.

e) Each case's elevated blood lead level incidence report shall be sent/submitted to the Department within seven days after the date of laboratory results. A local health authority or other facility shall submit all data received from a registered, permitted or licensed clinical laboratory or hospital laboratory to the Department within three business days after the date the data are received.

f) Every hospital, clinical or hospital laboratory, or other facility shall provide representatives of the Department with access to information including specified occupational disease cases or other cases specified for research studies related to occupational disease prevention and control. The Department will conduct studies of all medical, pathological, or other pertinent records and logs related to occupational disease incidence.

g) Every hospital, clinical or hospital laboratory, or other facility shall provide the Department representatives with the patient's name and attending physician's name for the purpose of follow-up on all laboratory and existing data base reports received by the Department.

h) The mode of access and the time during which this access will be provided shall be by mutual agreement between the hospital, other reporting facilities and the Department. The Department will not require hospitals and other reporting facilities to provide information on cases that are dated more than two years before the Department's request for further information.

(Source: Amended at 36 Ill. Reg. 8379, effective May 18, 2012)

Section 840.310 Methods of Reporting Occupational Disease

a) All registered, permitted, or licensed hospital laboratories, clinical laboratories, local health authorities or other facilities shall provide the Department with information on elevated blood lead level cases within seven business days after receipt of the results.

b) Health care providers' offices shall provide the Department with information on elevated blood lead level cases upon request of the Department or local health department.

c) Any person, clinical or hospital laboratory, hospital, or other facility required to report to the Department the occupational diseases specified in this Section, shall use the following terminology to indicate a reportable occupational disease:

1) Probable;

2) Consistent with;

3) Compatible with;

4) Suspected;

5) Extension or invasion "to", "onto", "into", "out onto".

d) If the following terminology would be used to report an occupational disease specified by the Department to be collected and submitted, the disease shall be interpreted as not being necessary for reporting to the Department:

1) Questionable;

2) Possible;

3) Suggests;

4) Equivocal;

5) Rule out;

6) Very close to;

7) Worrisome.

e) Determination of whether a given condition is reportable shall be made by the use of the International Classification of Diseases – 10^th Revision – Clinical Modification (ICD-10-CM) codes.

f) The specified diagnoses of occupationally related diseases that shall be collected from existing IDPH databases:

1) Asbestosis, ICD-10-CM code J61;

2) Coal Worker's Pneumoconiosis, ICD-10-CM code J60;

3) Lead Poisoning - (Elevated Blood Lead Level), ICD-10-CM code T56.0X; and

4) Silicosis, ICD-10-CM code J62.

g) All existing IDPH databases will use the ICD-10-CM codes specified in subsection (f) for consistency of data collection.

(Source: Amended at 46 Ill. Reg. 2971, effective February 1, 2022)

Section 840.APPENDIX A ISCR Incidence Report Form (Repealed)

Section 840.APPENDIX A ISCR Incidence Report Form (Repealed)

(Source: Repealed at 24 Ill. Reg. 3685, effective February 16, 2000)

Section 840.APPENDIX B Instructions for APORS Reporting (Repealed)

Section 840.EXHIBIT A Instructions for Completing Infant Discharge Record (Repealed)

(Source: Repealed at 24 Ill. Reg. 3685, effective February 16, 2000)

Section 840.EXHIBIT B Instructions for Completing Maternal Supplement (Repealed)

(Source: Repealed at 24 Ill. Reg. 3685, effective February 16, 2000)

Section 840.APPENDIX C Forms and Instructions for Occupational Disease Registry (Repealed)

Section 840.EXHIBIT A Instructions for completing The Laboratory Based Report of Adult Blood Lead Analysis (Repealed)

(Source: Repealed at 36 Ill. Reg. 8379, effective May 18, 2012)
Section 840.APPENDIX C Forms and Instructions for Occupational Disease Registry (Repealed)

Section 840.EXHIBIT B Instructions for completing the Health Department Follow-up Report of Adult Blood Lead Level Analysis For Results of 25 mcg/dl and Above (Local Health Authorities will use this form) (Repealed)

(Source: Repealed at 36 Ill. Reg. 8379, effective May 18, 2012)
Section 840.APPENDIX C Forms and Instructions for Occupational Disease Registry (Repealed)

Section 840.ILLUSTRATION A Health Department Laboratory Report of Adult Elevated Blood Lead Analysis 25 mcg/dl and Above (Repealed)

(Source: Repealed at 36 Ill. Reg. 8379, effective May 18, 2012)

Section 840.APPENDIX C Forms and Instructions for Occupational Disease Registry (Repealed)

Section 840.ILLUSTRATION B Health Department Follow-Up Report of Adult Blood Lead Levels Analysis for Results of 25 mcg/dl and Above (Repealed)

(Source: Repealed at 36 Ill. Reg. 8379, effective May 18, 2012)