reglab/statecodes huggingface dataset:
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 655 - PROBLEM PREGNANCY HEALTH SERVICES AND CARE PROJECTS › Section 655.30 - Standards

Current through Register Vol. 48, No. 28, July 12, 2024
a)
			 Comprehensiveness
Provisions shall be made for the development of a care plan for
				each client that assures effective interdisciplinary provision of comprehensive
				services. Comprehensive means completeness to ensure that all needed services
				are available, and continuity to ensure that services are received in an
				orderly fashion.
b)
			 Standards for Personnel
1) Applicants shall
			 give assurance that services will be provided by qualified personnel. Any
			 personnel required under State or local law to be licensed, certified, or
			 registered shall be appropriately licensed, certified, or registered.
2) Recommended minimum personnel
			 qualifications are as follows:
A) Physicians
			 - certification by specialty board (obstetrics and gynecology, neonatology
			 pediatrics) or in practice to complete requirements for examination for boards
			 (board eligible).
B) Nurses -
			 Certification of graduation from an approved school of nursing and a Bachelor
			 of Science degree in Nursing, with experience, preferably in obstetrics or
			 maternity nursing or in pediatric nursing.
C) Social Workers - Master's degree from an
			 accredited school of social work with previous experience in a health
			 agency.
D) Nutritionists - A
			 Bachelor's degree from an accredited 4 year college or university with a major
			 in foods and nutrition, experience as a nutritionist or dietician, and
			 completion of a hospital dietetic internship, or training and experience which
			 meets the requirements for membership in the American Dietetic
			 Association.
E) Health Educators -
			 Bachelor's degree with courses in health education and areas of concentration
			 in the behavioral and biological sciences and experience in community health
			 education.
F) Counselors -
			 Bachelor's degree from an accredited college or university in social work,
			 psychology, or closely related behavioral science discipline, and counseling
			 experience in related area.
3) Each project shall have a full time
			 project director. However, the Department may approve the appointment of a
			 project director who is employed less than full time where the Department finds
			 that such an appointment is consistent with the purposes of the
			 program.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 655 - PROBLEM PREGNANCY HEALTH SERVICES AND CARE PROJECTS › Section 655.40 - Use of Project Funds

Current through Register Vol. 48, No. 28, July 12, 2024
a)
1) When approved in the plan and budget,
			 funds may be used for the direct costs of operating and maintaining the
			 project.
2) The following direct
			 costs may be incurred:
A) Salaries, including
			 fringe benefits, for full or part-time professional personnel such as
			 physicians, nurses, social workers, counselors, nutritionists, dieticians,
			 physical therapists, technicians, health educators, and nonprofessional
			 personnel such as secretaries, typists, and clerks. The rate for personal
			 services shall not be more than that paid by the grantee to other comparable
			 employees in comparable positions, or if the grantee has no comparable
			 positions, the rate shall not be more than that paid for such services
			 elsewhere in the community. The fringe benefit rate shall not exceed that paid
			 to other employees of the agency.
B) Travel of personnel in carrying out the
			 activities approved in the plan.
3) Transportation of patients. Only payment
			 of the usual rates for the mode of travel that is consistent with the needs of
			 patients shall be included.
4)
			 Supplies, except for oral contraceptives or other birth control
			 devices.
5) Rental of facilities
			 where adequate space cannot be provided by the grantee agency. Rental charges
			 shall not exceed the lowest rate for comparable space in the
			 community.
6) Purchase of care,
			 including hospital in-patient and out-patient, and other services from
			 community facilities such as homemaker and visiting nurses. All other available
			 sources of reimbursement shall be exhausted first.
7) Other expenditures directly related to the
			 operation of the project such as telephone service, mimeographing, postage,
			 advertising, and other like items.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 655 - PROBLEM PREGNANCY HEALTH SERVICES AND CARE PROJECTS › Section 655.50 - Application Content and Process

Current through Register Vol. 48, No. 28, July 12, 2024
a)
			 Applications for grants under this authority shall be made in the format
			 specified in the "Application and Plan for Health Services Grant" (Form EBA 1,
			 available from Division of Family Health, Department of Human Services, 535
			 West Jefferson, Springfield, Illinois 62706).
b) Applications shall include a program
			 narrative which incorporates:
1) An
			 identification of the incidence of problem pregnancy and related problems in
			 the area to be served by the project;
2) A description of the economic conditions
			 and income level in the geographic area to be served;
3) A description of existing problem
			 pregnancy-related services including where, how, by whom and to whom they are
			 provided and the extent to which they are coordinated in the geographic area to
			 be served;
4) A description of
			 major unmet needs for services for those persons at risk of initial or repeat
			 problem pregnancies, the number of persons currently served in the area and the
			 number of persons not being served in the area;
5) A description of the core services to be
			 included in the project or provided by the grantee, to whom they will be
			 provided, how they will be linked, and their source of funding, to include
			 some, but not necessarily all, of the following:
A) Health and Mental Health
			 Counseling
B) Vocational
			 Counseling
C) Education services
			 which supplement regular school programs to help prevent adolescent pregnancy
			 and to assist pregnant adolescents and adolescent parents to remain in school
			 or to continue their education
D)
			 Primary and Preventive Health Services including Pre- and Post-Natal
			 Care
E) Nutrition Services and
			 Nutrition Information and Counseling
F) social services;
6) A description of how those persons needing
			 services other than those provided directly by the grantee will be identified
			 and how access and appropriate referral to those services will be
			 provided;
7) A description of the
			 fee schedule, if any, to be used for any services provided directly by the
			 grantee and the method by which it was derived;
8) A description of all the services and
			 activities to be linked, the results expected from the provision of such
			 services and activities, and a description of the procedures to be used for
			 evaluating those results;
9) A
			 description of the administrative structure of the agency or organization and
			 its staff, including curriculum vitae of professional staff (including
			 volunteer staff) of the agency who will be providing project
			 services;
10) Policies and
			 procedures manual of agency; and
11) Written agreements with service providers
			 and agencies with which the project will be linked.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 655 - PROBLEM PREGNANCY HEALTH SERVICES AND CARE PROJECTS › Section 655.60 - General Requirements

Current through Register Vol. 48, No. 28, July 12, 2024
a)
			 Grantees may charge fees for services paid with funds under this authority, but
			 only pursuant to an approved fee schedule which bases fees charged by the
			 grantee on the family size and the income of the service recipients, and an
			 assurance that the agency takes into account the difficulties some persons face
			 in obtaining resources to pay for services.
b) The grantee shall implement the program
			 within three months of the date when authorization to proceed is given. Funds
			 for programs not implemented within three months shall revert to unawarded
			 status unless a special extension is approved. A special extension shall be
			 approved if a grantee has made reasonable efforts to implement the project but
			 it is unable to do so within three months due to circumstances beyond its
			 control.
c) The grantee agency
			 shall allow periodic onsite review of its program and records by the staff of
			 the Division of Family Health or their authorized representatives.
d) The grantee agency shall submit quarterly
			 and annually fiscal, statistical, and narrative reports to the Division of
			 Family Health within 15 days at the end of each quarter.
e) Fees collected for services provided by
			 the project shall be used to further the purposes of the project and shall not
			 be used for match. Matching funds must not have been used for matching in any
			 other grant. In-kind contributions may be used for match.
f) Authorization for services for which
			 payments are made from project funds shall be maintained by the grantee. A form
			 for each patient shall show the services authorized and the amounts expended
			 for the specific types of services approved. The method proposed for
			 authorizing services allowable under project policies should be outlined in the
			 project plan.
g) Payment for
			 inpatient services shall be based on the lesser of reasonable cost of services
			 or the customary charges to the general public for such services.
h) Grantees shall not amend the plan or
			 budget without prior approval of the Department. The Department shall approve
			 amendments to a project plan or budget if such amendments are consistent with
			 the purposes and rules of the program and are reasonably justified.
i) The applicant shall maintain adequate
			 records to show disposition of all funds expended for activities for which the
			 grant was made. All records shall be retained for five years after the close of
			 the fiscal year in which the grant was made and shall be made available for
			 audit purposes upon request of the Department.
j) Failure by the grantee to comply with
			 these requirements shall be cause for discontinuance of funds or termination of
			 the grant.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 657 - MATERNAL DEATH REVIEW › Section 657.10 - Definition of Maternal Death

Current through Register Vol. 48, No. 28, July 12, 2024
Maternal Death is the death of any woman dying of any cause
				whatsoever while pregnant or within one year after the termination of the
				pregnancy, irrespective of the duration of the pregnancy at the time of the
				termination or the method by which it was terminated.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 657 - MATERNAL DEATH REVIEW › Section 657.20 - Reporting of Maternal Death

Current through Register Vol. 48, No. 28, July 12, 2024
In the event of a maternal death and when requested in writing
				by the Illinois Department of Public Health, any hospital, any coroner or
				medical examiner, or any health care provider, having contact with the
				deceased, shall provide one complete copy of pertinent medical records,
				including the autopsy report, to the Department.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 657 - MATERNAL DEATH REVIEW › Section 657.30 - Time Limit on Reporting

Current through Register Vol. 48, No. 28, July 12, 2024
The medical records and autopsy report pertinent to the
				maternal death shall be provided to the Department within 30 days after
				receipt, by the hospital, coroner, medical examiner, or health care provider,
				of the Department's written request.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 657 - MATERNAL DEATH REVIEW › Section 657.40 - Confidentiality of Records

Current through Register Vol. 48, No. 28, July 12, 2024
The Department of Public Health will keep all records
				confidential pursuant to federal law, Part 21 of Article VIII of the Code of
				Civil Procedure [735 ILCS 5 /Art. VIII, Part 21], and Section 5 of the Illinois
				Health Statistics Act [410 ILCS 520/5
				].
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart A - GENERAL PROVISIONS › Section 661.20 - Incorporated and Referenced Materials

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				The following federal and State statutes and rules guidelines are referenced in
				this Part:
1) Illinois Statutes:
A) Newborn Metabolic Screening Act
				[410 ILCS
				240 ]
B)
				Early Hearing Detection and Intervention Act [410 ILCS 213
				]
C) Genetic and Metabolic Diseases
				Advisory Committee Act [410 ILCS 465 ]
D) Nurse Practice Act [225 ILCS
				65 ]
E)
				Illinois Speech-Language Pathology and Audiology Practice Act [225 ILCS
				110 ]
F)
				Early Intervention Services System Act [325 ILCS 20
				]
G) Illinois Health Statistics Act
				[410 ILCS
				520 ]
H)
				Medical Studies Act [735 ILCS 5/8-2100 ]
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart A - GENERAL PROVISIONS › Section 661.30 - General Procedures for the Newborn Screening

Current through Register Vol. 48, No. 28, July 12, 2024
a) Pursuant to the Newborn Metabolic
				Screening Act [410 ILCS 240 ], the physician in
				attendance at or immediately after the birth of the newborn shall have primary
				responsibility for seeing that a newborn is screened in accordance with this
				Part. The physician may delegate the newborn screening to the medical care
				facility administrator or to the administrator's designated representative,
				such as a member of the nursery staff, the pediatrics staff, the laboratory
				director, the obstetrical supervisor, or other medical care facility
				official.
b) A newborn blood spot
				screening meeting the requirements for testing shall suffice for all tests
				other than the newborn hearing screening and newborn heart screening that are
				done at a medical care facility.
c)
				Pursuant to the Newborn Metabolic Screening Act, if the newborn is not born in
				or admitted to a hospital or when there is no primary care provider in
				attendance at or immediately after the birth, the primary care provider caring
				for the newborn during the first month of life shall be the individual
				responsible for seeing that newborn screening is performed within thirty (30)
				days after birth, unless a different time period is medically indicated. When
				there is no primary care provider caring for the newborn during this period,
				the parents or legal guardian are responsible. Local health authorities or the
				Department will assist the parents or legal guardian in having the newborn
				screened. [410 ILCS 240/2 (a-5)]
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart A - GENERAL PROVISIONS › Section 661.40 - Genetic and Metabolic Diseases Advisory Board

Current through Register Vol. 48, No. 28, July 12, 2024
a)
The Director shall create the
				Genetic and Metabolic Diseases Advisory Committee to advise the Department
				regarding issues relevant to newborn screenings of metabolic diseases
and other newborn non-metabolic conditions (Section 5(a) of the Genetic and
				Metabolic Diseases Advisory Committee Act).
b) The Advisory Committee shall:
1)
Advise the Department regarding
				issues relevant to its Genetic Program;
2)
Advise the Department regarding
				optimal laboratory methodologies for screening of the targeted
				conditions;
3)
Recommend to the Department consultants who are qualified to diagnose a
				condition detected by screening, provide management of care, and genetic
				counseling for the family;
4)
Monitor the incidence of each
				condition for which newborn screening is done, evaluate the effects of
				treatment and genetic counseling, and provide advice on disorders to be
				included in newborn screening panel;
5)
Advise the Department on
				educational programs for professionals and the general public;
and
6)
Advise the
				Department on new developments and areas of interest in relation to
				the
Department's
Genetics Program
(Section 5(b) of
				the Genetic and Metabolic Diseases Advisory Committee Act).
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart A - GENERAL PROVISIONS › Section 661.50 - Exemption

Current through Register Vol. 48, No. 28, July 12, 2024
Whenever a newborn screening test is not performed because a
				  parent or legal guardian
objects on the grounds that such test
				  conflicts with
their
religious tenets and practices, a written
				  statement of such objection shall be presented to the physician or other person
				  whose duty it is to administer and report such tests
. The medical care
				  facility or the health care provider shall maintain documentation of the
				  refusal as part of the newborn's, infant's or child's medical
				  record.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart A - GENERAL PROVISIONS › Section 661.60 - Fee Assessment and Payment

Current through Register Vol. 48, No. 28, July 12, 2024
a) Each
				institution or person submitting to the Department any sample for newborn
				screening shall be assessed a fee of $128. When the Director makes a
				determination to add screening for any additional disorders in the LSD
				category, pursuant to Section
				661.40, this fee shall be
				increased by $2 for each disorder added.
b) Monthly Statements of fee assessment shall
				be mailed to facilities submitting samples for analysis.
c) Payment shall be rendered to the
				Department upon receipt of the monthly statement of fee assessment.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart B - NEWBORN AND INFANT SCREENING REGISTRIES › Section 661.100 - Newborn Screening Registries

Current through Register Vol. 48, No. 28, July 12, 2024
The
Department shall maintain
a Newborn
				  Screening
Registry
or Registries to collect, store, analyze,
				  release, and report newborn blood spot, newborn hearing and newborn heart
				  screening data including the results of diagnosis and treatment for all
cases
identified. The Registry or Registries will include
				  information regarding patient and parent demographics, all screening,
				  diagnosis, treatment, intervention, follow-up, parent support, parent-to-parent
				  support and outcome evaluation of children diagnosed through newborn screening.
				  The Department will annually request updated information from the medical
				  specialist or primary care provider concerning developmental milestones for
				  each child diagnosed with a disorder, for which the Department screens, through
				  six years of age.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart B - NEWBORN AND INFANT SCREENING REGISTRIES › Section 661.110 - Early Hearing Detection and Intervention (EHDI) Registry

Current through Register Vol. 48, No. 28, July 12, 2024
a) The Department will
maintain a
				registry of cases
. The Department will
maintain a registry
				documenting screening, diagnosis, and intervention of cases of positive hearing
				screening results, including information needed for the purpose of follow-up
				services.
(Section 15 of the EHDI Act).
b)
Physicians, advanced practice
				registered nurses, physician assistants, otolaryngologists, audiologists,
				ancillary health care providers, early intervention programs and
				providers,
parent support,
parent-to-parent support programs,
				the Department of Human Services, and the University of Illinois at Chicago
				Division of Specialized Care for Children shall report all hearing testing,
				medical treatment, and intervention outcomes related to newborn hearing
				screening or newly identified hearing loss for children birth through 6 years
				of age to the Department,
including newborns, infants and children
				born out-of-state and in need of follow-up services in Illinois.
Reporting shall be done within 7 days after the date of service or
				after an inquiry from the Department.
(Section 10 of the EHDI Act).
Reports shall be submitted to the Department in a format determined by
				the Department
.
c) Medical
				care facilities shall submit the following for every newborn, infant or child
				to whom a newborn hearing screening test is administered:
1) Newborn, infant or child's name (first,
				middle and last);
2) Newborn,
				infant or child's date of birth;
3)
				Nursery, i.e., NICU, SCBU, well baby;
4) Newborn, infant or child's
				gender;
5) Newborn, infant or
				child's birth order;
6) Newborn,
				infant or child's place of birth;
7) Unique identification number assigned to
				newborn, infant or child's;
8) Full
				legal name of both parents;
9) Full
				legal name of legal guardian or caregiver, if applicable;
10) Date of birth of both parents;
11) Date of birth of legal guardian or
				caregiver, if applicable;
12) Time,
				date, screening technology and individual-ear screening results for each
				screening session;
13) Any risk
				factors for hearing loss;
14)
				Follow-up plan of care;
15) Medical
				care facility to where the newborn, infant or child is transferred, date of
				transfer and reason for transfer, if applicable;
16) Date of death for newborns, infant or
				children who expire prior to discharge, if applicable;
17) Name of the facility or physician
				submitting the test results; and
18) Address of facility or physician
				submitting the test results.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart B - NEWBORN AND INFANT SCREENING REGISTRIES › Section 661.130 - Data Submission

Current through Register Vol. 48, No. 28, July 12, 2024
a) The
				Registry shall be accessible to authorized users for the submission of
				information related to newborn blood spot, newborn hearing and newborn heart
				screening. Both demographic and newborn blood spot, newborn hearing and newborn
				heart screening data shall be reported by authorized users. Information shall
				include, but is not limited to:
1) Patient's
				name, date of birth, sex, telephone number, email address, home address,
				birthplace, and mother's legal name, as well as data concerning diagnosis,
				intervention, follow-up, parent support, parent-to-parent support and other
				outcomes for each child with a suspected or diagnosed condition through six
				years of age; and
2) Type of
				newborn screen, diagnosis, intervention, parent-to-parent support, parent
				support or follow-up administered, electronic health information such as Health
				Level 7 message, date of service, and identity of the provider who administered
				the newborn screen, diagnosis, intervention, parent support, parent-to-parent
				support or follow-up.
3) EHDI
				providers shall provide data to the EHDI Registry in accordance with Section
				661.110.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart B - NEWBORN AND INFANT SCREENING REGISTRIES › Section 661.140 - Provider Sites

Current through Register Vol. 48, No. 28, July 12, 2024
a) As a
				condition of enrollment in the Registry, the authorized user site shall enter
				into and agree to comply with an authorized user agreement with the Department
				and shall agree to use the Registry only for the confirmation of compliance
				with screening requirements, or the screening, diagnosis, intervention,
				treatment, or follow-up needs of patients, and assure that only the authorized
				user or their designee will have access to the Registry;
b) Each authorized user site staff member
				that requires access to the Registry shall sign an individual user agreement
				and confidentiality statement that shall be kept in the employee's personnel
				file.
c) In addition to the
				requirements of subsections (a) through (b), the authorized user Agreement will
				include the following provisions:
1) The
				authorized user will abide by the requirements of the confidentiality statement
				and is responsible for assuring that employees comply with confidentiality
				requirements.
2) The authorized
				user shall supply the name, address and type of health care provider; any
				additional sites under the same organization; the method of data submission;
				contact information; and the signature of the authorized user or their
				designee.
3) If the agreement is
				violated by unauthorized use of the Registry, the Department will terminate
				access to the Registry.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart B - NEWBORN AND INFANT SCREENING REGISTRIES › Section 661.150 - Individual User Agreement

Current through Register Vol. 48, No. 28, July 12, 2024
a) Each
				employee of an authorized user site who needs access to a Registry shall sign
				an individual authorized user agreement, which also includes a confidentiality
				statement. Patient-specific or provider-specific information is available only
				to authorized users.
b) Site
				managers shall notify the Department within 48 hours after any change in status
				of any Registry authorized users upon termination of employment or redefining
				of roles.
c) The Department will
				revoke the Registry access of an authorized user who misuses information
				contained in the Registry.
d)
				Authorized users are responsible for safeguarding their passwords and
				authorized user IDs and for protecting the security of the computer when a
				Registry session is open.
e) Any
				authorized user with a profile that is dormant for greater than 120 days shall
				be deactivated.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart C - NEWBORN BLOOD SPOT SCREENINGS › Section 661.210 - Blood Spot Reporting

Current through Register Vol. 48, No. 28, July 12, 2024
Any medical care facility or health care provider submitting
				  newborn screening specimens to the Illinois Department of Public Health
				  Laboratory shall comply with all requirements of this Part, and shall notify
				  the Department immediately whenever further testing on a newborn that was
				  performed by the medical care facility or another outside laboratory indicates
				  that:
a) phenylalanine levels are
				abnormal;
b) T4 determinations are
				abnormal or TSH determinations are abnormal;
c) total galactose or galactose-1-phosphate
				uridyl transferase determinations are abnormal;
d) 17-hydroxyprogesterone determinations are
				abnormal;
e) biotinidase enzyme
				determinations are abnormal;
f)
				abnormal hemoglobin patterns are identified;
g) abnormal amino acid or acylcarnitine
				patterns have been identified;
h)
				abnormal determinations that may indicate cystic fibrosis have been
				identified;
i) abnormal
				determinations that may indicate a lysosomal storage disorder have been
				identified;
j) abnormal
				determinations that may indicate severe combined immunodeficiency or T cell
				lymphopenia have been identified;
k) abnormal determinations that may indicate
				adrenoleukodystrophy have been identified; or
l) abnormal determinations that may indicate
				spinal muscular atrophy have been identified.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart C - NEWBORN BLOOD SPOT SCREENINGS › Section 661.220 - Retention of Specimens

Current through Register Vol. 48, No. 28, July 12, 2024
a) Blood
				spot samples received by the Department for newborn screening will be retained
				for a minimum of two months.
b) If
				all test results obtained from a blood spot sample are determined to be within
				normal range, the sample will be retained for a maximum of four
				months.
c) If any test result
				obtained from a blood spot sample is determined to be abnormal (i.e., out of
				normal range), the sample will be retained for a minimum of six
				years.
d) Based on need, blood spot
				samples with an abnormal result may be referred to other clinical laboratories
				for supplemental testing to further characterize the abnormality.
e) Blood spot samples that the Department
				retains may be used within the Department for quality control purposes as
				required under the Clinical Laboratory Improvement Amendments (CLIA).
f) With consent from the parent or legal
				guardian, any remaining sample, that is residual blood spot sample, may be
				released to a health care provider or designated laboratory for further
				analysis.
g) After the maximum time
				period for retention, the Department will destroy all blood spot samples.
				Residual blood spot sample destruction will be in accordance with the
				Department's laboratory standard operating procedures.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart C - NEWBORN BLOOD SPOT SCREENINGS › Section 661.230 - Designation of Medical Specialists

Current through Register Vol. 48, No. 28, July 12, 2024
The Department, with the advice of the University of Illinois
				  Division of Specialized Care for Children, and with the recommendation of the
				  Advisory Committee, will designate
consultants qualified to diagnose a
				  condition detected by screening, provide management of care, and genetic
				  counseling for the family
, to serve as medical specialists in
				  specified disease categories. These medical specialists should provide
clinical consultation and management of care, as indicated
by
				  newborn screening results, in collaboration with the primary care provider. The
				  minimum qualifications required for designation as a medical specialist are a
				  license to practice medicine in all its branches in Illinois, or licensure in
				  the state of practice, and certification by the American Board of Pediatrics or
				  equivalent board from another country. (Section
				  5.3 of
				  410 ILCS
				  265; Section 2 a
				  5.4 of
				  410 ILCS
				  240 )
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.300 - Adrenoleukodystrophy (ALD)

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by ALD
				will be identified by this screening, due to genetic variabilities and
				variations in health status, specimen quality, and timing of specimen
				collection, not all infants affected by the disorder may be identified. As with
				any laboratory test, false positive and false negative results are possible.
				Newborn screening test results are insufficient information on which to base
				diagnosis or treatment.
1) Using tandem mass
				spectrometry or other methods, ALD is indicated when an elevation of
				lysophosphatidylcholine (C26LPC) is detected in dried blood spots.
2) When the C26LPC levels are found to be
				abnormal, the Department will recommend a repeat newborn screening test or
				referral to a designated medical specialist for further diagnostic
				studies.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.310 - Biotinidase Deficiency

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by
				biotinidase deficiency will be identified by this screening, due to genetic
				variabilities and variations in health status, specimen quality, and timing of
				specimen collection, not all infants affected by the disorder may be
				identified. As with any laboratory test, false positive and false negative
				results are possible. Newborn screening test results are insufficient
				information on which to base diagnosis or treatment.
1) Laboratory tests for biotinidase
				deficiency are designed to detect a deficiency of the biotinidase enzyme.
				Normal test results indicate the presence of the enzyme. Test results are
				abnormal when the presence of the enzyme is not detected.
2) When the determination of the enzyme is
				deemed abnormal, the Department will recommend a repeat newborn blood spot
				screening test or referral of the newborn to a designated medical specialist
				for a quantitative determination of the biotinidase enzyme and further
				diagnostic studies.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.320 - Congenital Adrenal Hyperplasia (CAH) (Secondary to 21-hydroxylase deficiency)

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by CAH
				will be identified by this screening, due to genetic variabilities and
				variations in health status, specimen quality, and timing of specimen
				collection, not all infants affected by the disorder may be identified. As with
				any laboratory test, false positive and false negative results are possible.
				Newborn screening test results are insufficient information on which to base
				diagnosis or treatment.
1) Neonatal levels for
				17-hydroxyprogesterone vary with gestational age, birth weight, time of
				collection and in response to concurrent medical problems. Normal
				17-hydroxyprogesterone levels shall be established using accepted statistical
				techniques (for example, as described by the Association of Public Health
				Laboratories, see Section
				660.20) .
2) When the 17-hydroxyprogesterone level is
				deemed to be abnormal, the Department will recommend a repeat newborn blood
				spot screening test or referral of the newborn to a designated pediatric
				endocrinologist for further evaluation for CAH.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.330 - Congenital Hypothyroidism (CH)

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by CH will
				be identified by this screening, due to genetic variabilities and variations in
				health status, specimen quality, and timing of specimen collection, not all
				infants affected by the disorder may be identified. As with any laboratory
				test, false positive and false negative results are possible. Newborn screening
				test results are insufficient information on which to base diagnosis or
				treatment.
1) Neonatal levels for thyroid
				stimulating hormone (TSH) vary with gestational age, birth weight, time of
				collection and in response to concurrent medical problems. Normal TSH and
				normal thyroxine (T4) levels shall be established using accepted statistical
				techniques (for example, as described by the Association of Public Health
				Laboratories, see Section
				660.20) .
2) When the TSH level or the T4 level is
				deemed to be abnormal, the Department will recommend a repeat newborn blood
				spot screening test or referral of the newborn to a designated pediatric
				endocrinologist for further evaluation for CH and additional serum testing for
				thyroid function.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.340 - Cystic Fibrosis (CF)

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by CF will
				be identified by this screening, due to genetic variabilities and variations in
				health status, specimen quality, and timing of specimen collection, not all
				infants affected by the disorder may be identified. As with any laboratory
				test, false positive and false negative results are possible. Newborn screening
				test results are insufficient information on which to base diagnosis or
				treatment.
1) CF is indicated by elevated
				neonatal levels of immunoreactive trypsinogen (IRT) that can be detected in
				dried blood spots. The normal IRT range shall be established using accepted
				statistical techniques (for example, as described by the Association of Public
				Health Laboratories, see Section
				660.20) .
2) When elevated levels of IRT are detected,
				testing by genetic mutation analysis shall be performed as part of the newborn
				screen, to decrease false positive results. As there are over 1,000 mutations
				in the CF transmembrane conductance regulator (CFTR) gene, testing will yield
				only 90 to 95 percent sensitivity.
3) When IRT levels and/or mutation analysis
				are found to be abnormal indicating the possibility of CF, the Department will
				recommend referral of the newborn to a designated medical specialist for
				appropriate definitive testing and diagnostic studies.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.350 - Galactosemia

Current through Register Vol. 48, No. 28, July 12, 2024
a) Interpretation
				of Results. Although the majority of infants affected by galactosemia will be
				identified by this screening, due to genetic variabilities and variations in
				health status, specimen quality, and timing of specimen collection, not all
				infants affected by the disorder may be identified. As with any laboratory
				test, false positive and false negative results are possible. Newborn screening
				test results are insufficient information on which to base diagnosis or
				treatment.
1) Laboratory tests for
				galactosemia may be performed by testing for total galactose (galactose and
				galactose-1-phosphate) or a deficiency of the galactose-l-phosphate uridyl
				transferase enzyme. Normal test results indicate a normal level of total
				galactose or the presence of the enzyme. Test results are abnormal when the
				level of total galactose is above the normal range or the presence of the
				enzyme is reduced or not detected. Blood transfusion can cause a false negative
				test result for galactosemia for up to 120 days post-transfusion. Normal ranges
				shall be established using accepted statistical techniques (for example, as
				described by the Association of Public Health Laboratories, see Section
				660.20) .
2) When the galactose or enzyme levels are
				deemed abnormal, recommendations may be given to change the diet of the infant
				to a galactose free diet. The Department will recommend a repeat newborn
				screening test or referral of the newborn to a designated medical specialist
				for further diagnostic studies
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.360 - Lysosomal Storage Disorders (LSDs)

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by an LSD
				will be identified by this screening, due to genetic variabilities and
				variations in health status, specimen quality, and timing of specimen
				collection, not all infants affected by the disorder may be identified. As with
				any laboratory test, false positive and false negative results are possible.
				Newborn screening test results are insufficient information on which to base
				diagnosis or treatment.
1) An LSD can be
				detected in dried blood spots by using tandem mass spectrometry or other
				methods. Normal testing parameters shall be established using accepted
				statistical techniques (for example, as described by the Association of Public
				Health Laboratories, see Section
				660.20) .
2) When enzyme activity is found to be
				decreased, thus indicating the possibility of an LSD, the Department will
				recommend referral of the newborn to a designated medical specialist for
				appropriate definitive testing and diagnostic studies.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.370 - Amino Acid, Organic Acid and Fatty Acid Oxidation Disorders

Current through Register Vol. 48, No. 28, July 12, 2024
a) Interpretation
				of Results. Although the majority of infants affected by amino acid, organic
				acid and fatty acid oxidation disorders will be identified by this screening,
				due to genetic variabilities and variations in health status, specimen quality,
				and timing of specimen collection, not all infants affected by the disorder may
				be identified. As with any laboratory test, false positive and false negative
				results are possible. Newborn screening test results are insufficient
				information on which to base diagnosis or treatment.
1) The patient metabolite distribution
				patterns shall be compared to normal populations. Pattern analysis, and
				internal metabolite ratios relative to normal populations, shall be calculated
				using accepted statistical techniques (for example, as described by the
				Association of Public Health Laboratories, see Section
				660.20) .
2) When blood levels or ratios are found to
				be abnormal, indicating the possibility of a metabolic condition harmful to the
				infant, the Department will recommend a repeat newborn screening test or
				referral of the newborn to a designated medical specialist for appropriate
				definitive testing and diagnostic studies.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.380 - Severe Combined Immunodeficiency (SCID) and T-Cell Lymphopenia

Current through Register Vol. 48, No. 28, July 12, 2024
a) Interpretation
				of Results. Although the majority of infants affected by SCID or T-cell
				lymphopenia will be identified by this screening, due to genetic variabilities
				and variations in health status, specimen quality, and timing of specimen
				collection, not all infants affected by the disorder may be identified. As with
				any laboratory test, false positive and false negative results are possible.
				Newborn screening test results are insufficient information on which to base
				diagnosis or treatment.
1) SCID can be
				detected in dried blood spots by using DNA-based methods, such as polymerase
				chain reaction (PCR) or other methods. Normal testing parameters shall be
				established using accepted statistical techniques (for example, as described by
				the Association of Public Health Laboratories, see Section
				660.20) .
2) When screening results indicate the
				possibility of SCID or other T-cell lymphopenias, the Department will recommend
				referral of the newborn to a designated medical specialist for appropriate
				definitive testing and diagnostic studies
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.390 - Sickle Cell Disease/Trait and Other Hemoglobinopathies

Current through Register Vol. 48, No. 28, July 12, 2024
a) Interpretation of Results. Although the
				majority of infants affected by sickle cell disease/trait and other
				hemoglobinopathies will be identified by this screening, due to genetic
				variabilities and variations in health status, sample quality, and timing of
				sample collection, not all infants affected by the disorder may be identified.
				As with any laboratory test, false positive and false negative results are
				possible. Newborn screening test results are insufficient information on which
				to base diagnosis or treatment. Qualitative testing will determine the presence
				of various hemoglobins.
1) When hemoglobin F
				and hemoglobin S, but no hemoglobin A, are detected on the same sample, the
				Department will recommend referral to a designated medical specialist for
				follow-up and genetic counseling.
2) When hemoglobin F, hemoglobin S and
				hemoglobin C, but no hemoglobin A, are detected on the same sample, the
				Department will recommend referral to a designated medical specialist for
				follow-up and genetic counseling.
3) When hemoglobin F, hemoglobin A and
				hemoglobin C or hemoglobin F, hemoglobin A and hemoglobin S are detected on the
				same sample, the Department will recommend parental testing and genetic
				counseling by the attending physician or another qualified counselor.
4) When hemoglobin F and other hemoglobins,
				such as hemoglobin D, hemoglobin E or hemoglobin H (Bart's) are detected, the
				Department will recommend referral to a designated medical specialist for
				follow-up and genetic testing.
5)
				When hemoglobin A is detected as the predominant hemoglobin, and the blood spot
				sample was collected at less than two months of age, a written report will be
				sent to the submitter. The medical provider shall collect a repeat newborn
				screening blood spot sample at 120 days post-transfusion if the initial sample
				was collected post-transfusion.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart D - DETAILED PROCEDURES FOR NEWBORN BLOOD SPOT CONDITIONS › Section 661.400 - Spinal Muscular Atrophy (SMA)

Current through Register Vol. 48, No. 28, July 12, 2024
a)
				Interpretation of Results. Although the majority of infants affected by SMA
				will be identified by this screening, due to genetic variabilities and
				variations in health status, sample quality, and timing of sample collection,
				not all infants affected by the disorder may be identified. As with any
				laboratory test, false positive and false negative results are possible.
				Newborn screening test results are insufficient information on which to base
				diagnosis or treatment.
1) SMA is indicated
				when an SMN1 deletion is detected in dried blood spot samples by using
				DNA-based methods, such as polymerase chain reaction (PCR) or other methods.
				Normal testing parameters will be established using accepted statistical
				techniques (for example, as described by the Association of Public Health
				Laboratories, see Section
				660.20).
2) When the SMN1 deletion is found, thus
				indicating the possibility of SMA, the Department will recommend referral of
				the newborn to a designated medical specialist for appropriate definitive
				testing and diagnostic studies.
Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 661 - NEWBORN AND INFANT SCREENING AND TREATMENT CODE › Subpart E - DETAILED PROCEDURES FOR NEWBORN NON-METABOLIC CONDITIONS › Section 661.500 - Critical Congenital Heart Disease (CCHD)

Current through Register Vol. 48, No. 28, July 12, 2024
a) All newborns, including those in the
				neonatal intensive care unit, special care baby unit,
and birth
				centers
, shall receive pulse oximetry screening for critical
				congenital heart disease after 24 hours of age or before medical care facility
				discharge unless exempted from screening in accordance with subsection (b).
				[410 ILCS
				240/1.10 2b]
b) Newborns are exempt from pulse oximetry
				screening for CCHD if:
1) A religious
				exemption is filed by a parent or legal guardian;
2) A prenatal diagnosis of a cardiac defect
				has been determined; or
3) An
				echocardiogram has already been performed.