Subdivision 1. Duty to perform testing. (a) It is the duty of (1) the administrative officer or other person in charge of each institution caring for infants 28 days or less of age, (2) the person required in pursuance of the provisions of section 144.215, to register the birth of a child, or (3) the nurse midwife or midwife in attendance at the birth, to arrange to have administered to every infant or child in its care tests for heritable and congenital disorders according to subdivision 2 and rules prescribed by the state commissioner of health.
(b) Testing, recording of test results, reporting of test results, and follow-up of infants with heritable congenital disorders, including hearing loss detected through the early hearing detection and intervention program in section 144.966, shall be performed at the times and in the manner prescribed by the commissioner of health.
(c) The fee to support the newborn screening program, including tests administered under this section and section 144.966, shall be $177 per specimen. This fee amount shall be deposited in the state treasury and credited to the state government special revenue fund.
(d) The fee to offset the cost of the support services provided under section 144.966, subdivision 3a, shall be $15 per specimen. This fee shall be deposited in the state treasury and credited to the general fund.
Subd. 2. Determination of tests to be administered. The commissioner shall periodically revise the list of tests to be administered for determining the presence of a heritable or congenital disorder. Revisions to the list shall reflect advances in medical science, new and improved testing methods, or other factors that will improve the public health. In determining whether a test must be administered, the commissioner shall take into consideration the adequacy of analytical methods to detect the heritable or congenital disorder, the ability to treat or prevent medical conditions caused by the heritable or congenital disorder, and the severity of the medical conditions caused by the heritable or congenital disorder. The list of tests to be performed may be revised if the changes are recommended by the advisory committee established under section 144.1255, approved by the commissioner, and published in the State Register. The revision is exempt from the rulemaking requirements in chapter 14, and sections 14.385 and 14.386 do not apply.
Subd. 3. Information provided to parents and legal guardians. (a) The department shall make information and forms available to childbirth education programs and health care providers who provide prenatal care describing the newborn screening program and the provisions of this section to be used in a discussion with expectant parents and parents of newborns. The department shall promote the materials describing the newborn screening program and encourage providers and education programs to thoroughly discuss the program with expectant parents and parents with newborns. The department shall make information and forms about newborn screening available to the persons with a duty to perform testing under this section and to expectant parents and parents of newborns using electronic and other means.
(b) Prior to collecting a sample, persons with a duty to perform testing under subdivision 1 must:
(1) provide parents or legal guardians of infants with a document that provides the following information:
(i) the benefits of newborn screening;
(ii) that the blood sample will be used to test for heritable and congenital disorders, as determined under subdivision 2;
(iii) the data that will be collected as part of the testing;
(iv) the benefits associated with the department's storage of an infant's blood sample and test results;
(v) that the Department of Health may store the blood samples and test results unless the parents or legal guardians elect to not have them stored;
(vi) that blood samples and test results will be used for program operations in accordance with subdivision 5, unless the parents or legal guardians elect not to have the blood samples and test results stored, in which case the blood samples and test results will be destroyed in accordance with subdivision 8, paragraph (b), and until destroyed will only be used for program operations described under subdivision 5, paragraph (a), clauses (1) to (7);
(vii) that parents or legal guardians have a right to elect not to have newborn screening performed and a right to secure private testing;
(viii) that parents or legal guardians have a right to elect to have the newborn screening performed, but not have the blood samples and test results stored;
(ix) that parents or legal guardians have a right to authorize in writing that the blood samples and test results may be used for public health studies or research; and
(x) the Department of Health's website address where more information and forms may be obtained; and
(2) upon request, promptly provide parents or legal guardians of infants with forms necessary to request that the infant not have blood collected for testing or to request to have the newborn screening performed, but not have the blood samples and test results stored; and
(3) record in the infant's medical record that a parent or legal guardian of the infant has received the information provided pursuant to this subdivision and has had an opportunity to ask questions.
(c) Nothing in this section prohibits a parent or legal guardian of an infant from having newborn screening performed by a private entity.
Subd. 4. Parental options. (a) The parent or legal guardian of an infant otherwise subject to testing under this section may elect not to have newborn screening performed, or may elect to have newborn screening tests performed, but not to have the blood samples and test results stored.
(b) If a parent or legal guardian elects not to have newborn screening performed or elects not to allow the blood samples and test results to be stored, then the election must be recorded on a form that is signed by the parent or legal guardian. The signed form must be made part of the infant's medical record and a copy shall be provided to the Department of Health. When a parent or legal guardian elects not to have newborn screening performed, the person with the duty to perform testing under subdivision 1 must follow that election. A written election to decline testing exempts persons with a duty to perform testing and the Department of Health from the requirements of this section and section 144.128.
Subd. 5. Newborn screening program operations. (a) "Newborn screening program operations" means actions, testing, and procedures directly related to the operation of the newborn screening program, limited to the following:
(1) confirmatory testing;
(2) laboratory quality control assurance and improvement;
(3) calibration of equipment;
(4) evaluating and improving the accuracy of newborn screening tests for conditions approved for screening in Minnesota;
(5) validation of equipment and screening methods;
(6) continuity of operations to ensure testing can continue as required by Minnesota law in the event of an emergency;
(7) follow-up services for the cases of heritable and congenital disorders identified by newborn screening; and
(8) utilization of blood samples and test results for studies related to newborn screening, including studies used to develop new tests.
(b) No research or public health studies other than those described in paragraph (a) shall be conducted without written consent as described under subdivision 7.
(c) Any sale of bloodspots, test results, or other data collected in the newborn screening program is strictly prohibited.
Subd. 6. [Repealed, 2014 c 203 s 8]
Subd. 7. Parental options for additional research. (a) The parent or legal guardian of an infant subject to testing under this section, or an individual who was tested as an infant if the individual is 18 years of age or older may authorize in writing that the infant's blood sample and test results be retained and used by the Department of Health for the purposes described in subdivision 9.
(b) The Department of Health must provide a consent form, with an attached Tennessen warning pursuant to section 13.04, subdivision 2. The consent form must provide the following:
(1) information as to the personal identification and use of samples and test results for public health studies or research not related to newborn screening;
(2) information that explains that, upon approval by the Department of Health's Institutional Review Board, blood samples and test results may be shared with external parties for public health studies or research; and
(3) information that explains that blood samples contain various components, including deoxyribonucleic acid (DNA).
Subd. 8. Storage and use of samples and test results. (a) Except as limited under paragraph (b), the Department of Health may store blood samples and test results, and may use the blood samples and test results in accordance with subdivision 5. If written informed consent of a parent, legal guardian, or individual is obtained under subdivision 7, the Department of Health may use the blood samples and test results in accordance with subdivision 9.
(b) If a parent, legal guardian, or individual elects against storage, or revokes prior consent for storage, the blood samples must be destroyed within 30 days after receipt of the request, and test results must be destroyed within 30 days after receipt of the request, or the earliest time allowed under Clinical Laboratory Improvement Amendments (CLIA) regulations, whichever is later. Until destroyed, the blood samples and test results may be used for program operations described under subdivision 5, paragraph (a), clauses (1) to (7).
Subd. 9. Written, informed consent for other use of samples and test results. With the written, informed consent of a parent or legal guardian, the Department of Health may use blood samples and test results for public health studies or research not related to newborn screening, and upon approval by the Department of Health's Institutional Review Board, share samples and test results with external parties for public health studies or research.
Subd. 10. Revoking consent for storage and use. A parent or legal guardian, or the individual whose blood was tested as an infant if the individual is 18 years of age or older, may revoke approval for storage or use of blood samples or test results at any time by providing a signed and dated form requesting destruction of the blood samples or test results. Blood samples and test results must be destroyed as specified under subdivision 8, paragraph (b).
1965 c 205 s 1; 1977 c 305 s 45; 1Sp1981 c 4 art 1 s 75; 1985 c 248 s 70; 1986 c 444; 1988 c 689 art 2 s 31; 1994 c 636 art 2 s 2; 1997 c 203 art 2 s 11; 1997 c 205 s 19; 1Sp2003 c 14 art 7 s 26; 2007 c 147 art 16 s 7; 2009 c 79 art 10 s 5; 2012 c 292 art 4 s 3-10; 2013 c 108 art 12 s 14; 2013 c 125 art 1 s 30; 2014 c 203 s 1-7; 1Sp2021 c 7 art 3 s 20
Structure Minnesota Statutes
Chapter 144 — Department Of Health
Section 144.011 — Department Of Health.
Section 144.05 — General Duties Of Commissioner; Reports.
Section 144.0505 — Cooperation With Commissioner Of Human Services.
Section 144.051 — Data Relating To Licensed And Registered Persons.
Section 144.052 — Use Of Data.
Section 144.0525 — Epidemiologic Studies; Health Hazards; Health Surveillance.
Section 144.053 — Research Studies Confidential.
Section 144.0535 — Entry For Inspection.
Section 144.054 — Subpoena Power.
Section 144.055 — Home Safety Programs.
Section 144.056 — Plain Language In Written Materials.
Section 144.057 — Background Studies On Licensees And Other Personnel.
Section 144.058 — Interpreter Services Quality Initiative.
Section 144.059 — Palliative Care Advisory Council.
Section 144.06 — State Commissioner Of Health To Provide Instruction.
Section 144.061 — Early Dental Prevention Initiative.
Section 144.062 — Vaccine Cost Reduction Program.
Section 144.064 — The Vivian Act.
Section 144.065 — Prevention And Treatment Of Sexually Transmitted Infections.
Section 144.07 — Powers Of Commissioner.
Section 144.0721 — Assessments Of Care And Services To Nursing Home Residents.
Section 144.0724 — Resident Reimbursement Classification.
Section 144.074 — Funds Received From Other Sources.
Section 144.0742 — Contracts For Provision Of Public Health Services.
Section 144.0751 — Health Standards.
Section 144.077 — Mobile Health Care Providers.
Section 144.09 — Cooperation With Federal Authorities.
Section 144.092 — Coordinated Nutrition Data Collection.
Section 144.10 — Federal Aid For Maternal And Child Welfare Services.
Section 144.111 — Rules, Notice Published.
Section 144.12 — Regulation, Enforcement, Licenses, Fees.
Section 144.1201 — Definitions.
Section 144.1202 — United States Nuclear Regulatory Commission Agreement.
Section 144.1203 — Training; Rulemaking.
Section 144.1204 — Surety Requirements.
Section 144.1205 — Radioactive Material; Special Nuclear Material.
Section 144.121 — X-ray Machines; Other Sources Of Ionizing Radiation.
Section 144.1212 — Notice To Patient; Mammogram Results.
Section 144.1215 — Authorization To Use Handheld Dental X-ray Equipment.
Section 144.122 — License, Permit, And Survey Fees.
Section 144.1222 — Public Pools; Enclosed Sports Arenas.
Section 144.1225 — Advanced Diagnostic Imaging Services.
Section 144.123 — Fees For Diagnostic Laboratory Services; Exceptions.
Section 144.125 — Tests Of Infants For Heritable And Congenital Disorders.
Section 144.1251 — Newborn Screening For Critical Congenital Heart Disease (cchd).
Section 144.1255 — Heritable And Congenital Disorders.
Section 144.128 — Commissioner's Duties.
Section 144.14 — Quarantine Of Interstate Carriers.
Section 144.145 — Fluoridation Of Municipal Water Supplies.
Section 144.1461 — Dignity In Pregnancy And Childbirth.
Section 144.1464 — Summer Health Care Interns.
Section 144.1465 — Finding And Purpose.
Section 144.147 — Rural Hospital Planning And Transition Grant Program.
Section 144.1476 — Rural Pharmacy Planning And Transition Grant Program.
Section 144.148 — Rural Hospital Capital Improvement Grant Program.
Section 144.1481 — Rural Health Advisory Committee.
Section 144.1482 — Office Of Rural Health.
Section 144.1483 — Rural Health Initiatives.
Section 144.1485 — Database On Health Personnel.
Section 144.1492 — State Rural Health Network Reform Initiative.
Section 144.1493 — Nursing Grant Program.
Section 144.1501 — Health Professional Education Loan Forgiveness Program.
Section 144.1505 — Health Professionals Clinical Training Expansion Grant Program.
Section 144.1506 — Primary Care Residency Expansion Grant Program.
Section 144.1911 — International Medical Graduates Assistance Program.
Section 144.1912 — Greater Minnesota Family Medicine Residency Grant Program.
Section 144.193 — Inventory Of Biological And Health Data.
Section 144.212 — Definitions.
Section 144.213 — Office Of Vital Records.
Section 144.2131 — Security Of Vital Records System.
Section 144.215 — Birth Registration.
Section 144.2151 — Record Of Birth Resulting In Stillbirth.
Section 144.216 — Foundling Registration.
Section 144.217 — Delayed Records Of Birth.
Section 144.218 — Replacement Birth Records.
Section 144.2181 — Amendment And Correction Of Vital Records.
Section 144.221 — Death Registration.
Section 144.2215 — Minnesota Birth Defects Information System.
Section 144.2216 — Birth Defects Records And Reports Required.
Section 144.2217 — Classification Of Birth Defects Information.
Section 144.2218 — Transfers Of Information To Other Government Agencies.
Section 144.2219 — Transfers Of Information To Research Entities.
Section 144.222 — Reports Of Fetal Or Infant Death.
Section 144.223 — Report Of Marriage.
Section 144.225 — Disclosure Of Information From Vital Records.
Section 144.2252 — Access To Original Birth Record After Adoption.
Section 144.2255 — Certified Birth Record For Homeless Youth.
Section 144.29 — Health Records; Children Of School Age.
Section 144.291 — Minnesota Health Records Act.
Section 144.292 — Patient Rights.
Section 144.293 — Release Or Disclosure Of Health Records.
Section 144.294 — Records Relating To Mental Health.
Section 144.295 — Disclosure Of Health Records For External Research.
Section 144.296 — Copies Of Videotapes.
Section 144.297 — Independent Medical Examination.
Section 144.30 — Copies Of Records Evidence In Juvenile Court.
Section 144.32 — False Statements Cause For Discharge.
Section 144.334 — Right To Request Patient Information.
Section 144.3345 — Interconnected Electronic Health Record Grants.
Section 144.3351 — Immunization Data.
Section 144.3352 — Hepatitis B Maternal Carrier Data; Infant Immunization.
Section 144.336 — Registry Of Persons Typed For Human Leukocyte Antigens.
Section 144.34 — Investigation And Control Of Occupational Diseases.
Section 144.341 — Living Apart From Parents And Managing Financial Affairs.
Section 144.342 — Marriage Or Giving Birth, Consent For Health Service For Self Or Child.
Section 144.343 — Pregnancy, Venereal Disease, Alcohol Or Drug Abuse, Abortion.
Section 144.344 — Emergency Treatment.
Section 144.3441 — Hepatitis B Vaccination.
Section 144.345 — Representations To Persons Rendering Service.
Section 144.346 — Information To Parents.
Section 144.347 — Financial Responsibility.
Section 144.35 — Pollution Of Water.
Section 144.36 — Appeal To District Court.
Section 144.37 — Other Remedies Preserved.
Section 144.382 — Definitions.
Section 144.383 — Authority Of Commissioner.
Section 144.384 — Notice Of Violation.
Section 144.385 — Public Notice.
Section 144.3855 — Limitation.
Section 144.3872 — Female Genital Mutilation; Education And Outreach.
Section 144.391 — Public Policy.
Section 144.392 — Duties Of Commissioner.
Section 144.393 — Public Communications Program.
Section 144.394 — Health Promotion And Education.
Section 144.396 — Tobacco Use Prevention.
Section 144.397 — Statewide Tobacco Cessation Services.
Section 144.412 — Public Policy.
Section 144.413 — Definitions.
Section 144.414 — Prohibitions.
Section 144.416 — Responsibilities Of Proprietors.
Section 144.4165 — Tobacco Products Prohibited In Public Schools.
Section 144.4167 — Permitted Smoking.
Section 144.417 — Commissioner Of Health, Enforcement, Penalties.
Section 144.4172 — Definitions.
Section 144.4173 — Cause Of Action.
Section 144.4176 — Petition; Notice.
Section 144.4177 — Time Of Hearing And Duties Of Counsel.
Section 144.4178 — Criminal Immunity.
Section 144.4179 — Standard Of Proof; Evidence.
Section 144.4182 — Temporary Emergency Hold.
Section 144.4183 — Emergency Hold Hearing.
Section 144.4184 — Contact Data.
Section 144.4186 — Data Privacy.
Section 144.419 — Isolation And Quarantine Of Persons.
Section 144.4195 — Due Process For Isolation Or Quarantine Of Persons.
Section 144.4196 — Employee Protection.
Section 144.4197 — Emergency Vaccine Administration; Legend Drug.
Section 144.4198 — Mass Dispensing Under Authority Of Commissioner Of Health.
Section 144.4199 — Public Health Response Contingency Account.
Section 144.441 — Tuberculosis Screening In Schools.
Section 144.442 — Testing In School Clinics.
Section 144.445 — Tuberculosis Screening In Correctional Institutions.
Section 144.4803 — Definitions.
Section 144.4804 — Reporting Relating To Tuberculosis.
Section 144.4805 — Health Order; Rights Of Carrier And Respondent.
Section 144.4806 — Preventive Measures Under Health Order.
Section 144.4807 — Notice Of Obligation To Isolate Or Examine.
Section 144.4808 — Apprehend And Hold Order.
Section 144.4809 — Preliminary Hearing.
Section 144.4810 — Final Hearing.
Section 144.4811 — Periodic Review And Release From Detention.
Section 144.4812 — Costs Of Care.
Section 144.4813 — Data Privacy.
Section 144.49 — Violations; Penalties.
Section 144.492 — Definitions.
Section 144.494 — Designating Stroke Centers And Stroke Hospitals.
Section 144.4941 — St Segment Elevation Myocardial Infarction (stemi) Receiving Centers.
Section 144.495 — Formaldehyde Rules.
Section 144.496 — Minnesota Radon Awareness Act.
Section 144.4961 — Minnesota Radon Licensing Act.
Section 144.497 — St Elevation Myocardial Infarction.
Section 144.50 — Hospitals, Licenses; Definitions.
Section 144.51 — License Applications.
Section 144.55 — Licenses; Issuance, Suspension And Revocation.
Section 144.5509 — Radiation Therapy Facility Construction.
Section 144.551 — Hospital Construction Moratorium.
Section 144.552 — Public Interest Review.
Section 144.553 — Alternative Approval Process.
Section 144.554 — Health Facilities Construction Plan Submittal And Fees.
Section 144.561 — Description Of Certain Medical Facilities.
Section 144.562 — Swing Bed Approval; Issuance Of License Conditions.
Section 144.563 — Nursing Services Provided In A Hospital; Prohibited Practices.
Section 144.564 — Monitoring Of Subacute Or Transitional Care Services.
Section 144.565 — Diagnostic Imaging Facilities.
Section 144.566 — Violence Against Health Care Workers.
Section 144.572 — Institutions Excepted.
Section 144.573 — Pets In Certain Institutions.
Section 144.574 — Dangers Of Shaking Infants And Young Children.
Section 144.58 — Information, Confidential.
Section 144.581 — Hospital Authorities.
Section 144.585 — Methicillin-resistant Staphylococcus Aureus Control Programs.
Section 144.586 — Requirements For Certain Notices And Discharge Planning.
Section 144.591 — Disclosure Of Hospital Charges.
Section 144.602 — Definitions.
Section 144.603 — Statewide Trauma System Criteria.
Section 144.604 — Trauma Triage And Transportation.
Section 144.605 — Designating Trauma Hospitals.
Section 144.606 — Interhospital Transfers.
Section 144.6062 — Comprehensive Advanced Life Support.
Section 144.6071 — Trauma Registry.
Section 144.608 — Trauma Advisory Council.
Section 144.611 — Captioning Required.
Section 144.615 — Birth Centers.
Section 144.6501 — Nursing Home Admission Contracts.
Section 144.6502 — Electronic Monitoring In Certain Facilities.
Section 144.6503 — Facilities For Alzheimer's Disease Or Related Disorder.
Section 144.6505 — Subacute Care Waivers.
Section 144.651 — Health Care Bill Of Rights.
Section 144.6512 — Retaliation In Nursing Homes Prohibited.
Section 144.652 — Bill Of Rights Notice To Patient Or Resident; Violation.
Section 144.6521 — Disclosure Of Financial Interest.
Section 144.6522 — Designation Of A Caregiver.
Section 144.653 — Rules; Periodic Inspections; Enforcement.
Section 144.6535 — Variance Or Waiver.
Section 144.654 — Experts May Be Employed.
Section 144.655 — Program For Voluntary Medical Aid.
Section 144.656 — Employees To Be Compensated.
Section 144.657 — Volunteer Efforts Encouraged.
Section 144.658 — Epidemiologic Data Discovery.
Section 144.6581 — Determination Of Whether Data Identifies Individuals.
Section 144.6585 — Identification Of Health Care Providers.
Section 144.6586 — Notice Of Rights To Sexual Assault Victim.
Section 144.661 — Definitions.
Section 144.662 — Traumatic Brain Injury And Spinal Cord Injury Registry.
Section 144.663 — Duty To Report.
Section 144.664 — Duties Of Commissioner.
Section 144.665 — Traumatic Brain Injury And Spinal Cord Injury Data.
Section 144.671 — Cancer Surveillance System; Purpose.
Section 144.672 — Duties Of Commissioner; Rules.
Section 144.68 — Records And Reports Required.
Section 144.69 — Classification Of Data On Individuals.
Section 144.691 — Grievance Procedures.
Section 144.696 — Definitions.
Section 144.697 — General Powers And Duties Of State Commissioner Of Health.
Section 144.698 — Reporting Requirements.
Section 144.699 — Continuing Analysis.
Section 144.70 — Biennial Report.
Section 144.701 — Rate Disclosure.
Section 144.702 — Hospital And Outpatient Surgical Center Costs.
Section 144.7022 — Reporting Organizations; Penalty Orders.
Section 144.703 — Additional Powers.
Section 144.7055 — Staffing Plan Reports.
Section 144.7063 — Definitions.
Section 144.7065 — Facility Requirements To Report, Analyze, And Correct.
Section 144.7067 — Commissioner Duties And Responsibilities.
Section 144.7068 — Reports From Licensing Boards.
Section 144.7069 — Interstate Coordination; Reports.
Section 144.71 — Purpose; Definitions.
Section 144.73 — State Commissioner Of Health, Duties.
Section 144.74 — Rules, Standards.
Section 144.7401 — Definitions.
Section 144.7402 — Conditions For Applicability Of Procedures.
Section 144.7403 — Information Required To Be Given To Individuals.
Section 144.7404 — Disclosure Of Positive Blood-borne Pathogen Test Results.
Section 144.7405 — Consent Procedures Generally.
Section 144.7406 — Testing Of Available Blood.
Section 144.7407 — Blood Sample Collection For Testing.
Section 144.7408 — No Discrimination.
Section 144.7409 — Use Of Test Results.
Section 144.7411 — Test Information Confidentiality.
Section 144.7412 — Penalty For Unauthorized Release Of Information.
Section 144.7413 — Responsibility For Testing And Treatment; Costs.
Section 144.7414 — Protocols For Exposure To Blood-borne Pathogens.
Section 144.7415 — Penalties And Immunity.
Section 144.84 — Civil Service Classification.
Section 144.91 — Powers And Duties.
Section 144.92 — Grants Or Gifts.
Section 144.945 — Zika Preparedness And Response.
Section 144.95 — Mosquito Research Program.
Section 144.9501 — Definitions.
Section 144.9502 — Statewide Lead Surveillance System.
Section 144.9503 — Primary Prevention.
Section 144.9504 — Secondary Prevention.
Section 144.9505 — Credentialing Of Lead Firms And Professionals.
Section 144.9507 — Lead-related Funding.
Section 144.9509 — Enforcement.
Section 144.9512 — Lead Abatement Program.
Section 144.9513 — Healthy Housing Grants.
Section 144.966 — Early Hearing Detection And Intervention Program.
Section 144.98 — Accreditation Of Environmental Laboratories.
Section 144.989 — Title; Citation.
Section 144.991 — Administrative Penalty Order Procedure.
Section 144.992 — False Information.
Section 144.993 — Recovery Of Litigation Costs And Expenses.
Section 144.995 — Definitions; Environmental Health Tracking And Biomonitoring.
Section 144.996 — Environmental Health Tracking; Biomonitoring.
Section 144.997 — Biomonitoring Pilot Program.
Section 144.998 — Environmental Health Tracking And Biomonitoring Advisory Panel.