Newborn Screening Regulations, P-37.1 Reg 15

1 NEWBORN SCREENING P-37.1 REG 15 The Newborn Screening Regulations being Chapter P-37.1 Reg 15 (effective August 1, 2014) as amended by Saskatchewan Regulations 54/2023. NOTE: This consolidation is not official. Amendments have been incorporated for convenience of reference and the original statutes and regulations should be consulted for all purposes of interpretation and application of the law. In order to preserve the integrity of the original statutes and regulations, errors that may have appeared are reproduced in this consolidation. 2 P-37.1 REG 15 NEWBORN SCREENING Table of Contents PART I PART V Preliminary Matters Further Tests and Contact by Regional 1 Title Health Authority 2 Interpretation 10 Further tests PART II 11 Notification to laboratory Program Administration PART VI 3 Program established Disclosure and Request 4 Guidelines adopted of Information 5 Program delivery 12 Laboratory may request information PART III PART VII Sample Collection Coming into Force 6 Blood sample required 13 Coming into force 7 Submission of sample Appendix PART IV Form 1 Refusal of Newborn Screening Tests and Results 8 Tests to be conducted 9 Results to be recorded 3 NEWBORN SCREENING P-37.1 REG 15 CHAPTER P-37.1 REG 15 The Public Health Act, 1994 PART I Preliminary Matters Title 1 These regulations may be cited as The Newborn Screening Regulations. Interpretation 2 In these regulations: (a) “Act” means The Public Health Act, 1994; (b) “affiliate” means an affiliate as defined in The Provincial Health Authority Act; (c) “guidelines” means the Saskatchewan Newborn Screening Guidelines adopted pursuant to section 4; (d) Repealed. 14 Jly 2023 SR 54/2023 s3. (e) “laboratory” means: (i) a laboratory established pursuant to section 8 of The Health Administration Act; or (ii) any other laboratory approved by the minister pursuant to section 3; (f) “newborn” means an infant under 121 days of age; (g) “newborn screening program” means the program established pursuant to section 3; (h) “personal information” means personal information within the meaning of The Freedom of Information and Protection of Privacy Act; (i) “personal health information” means personal health information within the meaning of The Health Information Protection Act; (i.1) “physician assistant” means a physician assistant as defined in The Medical Profession Act, 1981 who is practising under the supervision of a physician as approved by the College of Physicians and Surgeons of Saskatchewan; (j) “practitioner” means: (i) a physician; (ii) a midwife who is entitled to practise midwifery pursuant to The Midwifery Act; (iii) a nurse practitioner; or (iv) a physician assistant; 4 P-37.1 REG 15 NEWBORN SCREENING (k) “screenable disease” means a disease listed in the guidelines as a disease for which a screening test is available. 8 Aug 2014 cP-37.1 Reg 15 s2; 14 Jly 2023 SR 54/2023 s3. PART II Program Administration Program established 3(1) The newborn screening program is established for the purpose of aiding in the detection, prevention and control of screenable diseases in newborns. (2) All newborns who are born in Saskatchewan, regardless of their place of residence, are eligible for testing under the newborn screening program. (3) For the purposes of these regulations, the minister may approve any laboratory that the minister is satisfied is capable of conducting tests for the newborn screening program to perform that testing. 8 Aug 2014 cP-37.1 Reg 15 s3. Guidelines adopted 4(1) The Saskatchewan Newborn Screening Guidelines, dated March 2012 and prepared by the Ministry of Health, as amended from time to time, are adopted for the purposes of these regulations, pursuant to clause 46(1)(ii) of the Act. (2) The minister shall: (a) cause the guidelines to be made available to the public in any form or manner that the minister considers appropriate; and (b) take any steps that the minister considers appropriate to bring the guidelines, and the manner and form in which the guidelines are available, to the attention of the public. 8 Aug 2014 cP-37.1 Reg 15 s4. Program delivery 5(1) Every local authority and every affiliate that provides obstetrical services shall administer the newborn screening program within the facilities that the local authority or affiliate operates. (2) Every local authority shall designate a person as the person responsible for the newborn screening program in the local authority’s jurisdictional area. 8 Aug 2014 cP-37.1 Reg 15 s5; 14 Jly 2023 SR 54/2023 s4. 5 NEWBORN SCREENING P-37.1 REG 15 PART III Sample Collection Blood sample required 6(1) Subject to subsection (4), for the purposes of the newborn screening program, every local authority and every affiliate that provides obstetrical services shall collect a blood sample from every newborn born in a facility that the local authority or affiliate operates. (2) Subject to subsection (4), if a local authority becomes aware that a newborn residing in its jurisdictional area has not had a blood sample collected for the purposes of the newborn screening program, the local authority shall take all reasonable steps to: (a) contact a parent or guardian of the newborn for the purpose of having the newborn tested under the newborn screening program; and (b) collect a blood sample from the newborn. (3) The local authority or affiliate shall collect all blood samples required pursuant to these regulations in accordance with the guidelines. (4) Subsections (1) and (2) do not apply if a parent or guardian of a newborn has completed Form 1 of the Appendix and submitted it to: (a) the local authority or affiliate that operates the facility in which the newborn was born; or (b) the practitioner who is responsible for the care of the newborn. 8 Aug 2014 cP-37.1 Reg 15 s6; 14 Jly 2023 SR 54/2023 s5. Submission of sample 7 A local authority or an affiliate that collects a blood sample pursuant to these regulations shall send the sample to a laboratory as soon as possible but not later than 72 hours after collection. 8 Aug 2014 cP-37.1 Reg 15 s7; 14 Jly 2023 SR 54/2023 s6. PART IV Tests and Results Tests to be conducted 8 On receipt of a sample collected pursuant to these regulations, a laboratory shall: (a) conduct the necessary tests for screenable diseases as set out in the guidelines; and 6 P-37.1 REG 15 NEWBORN SCREENING (b) within 48 hours after completion of the tests mentioned in clause (a), provide a written report of the test results to: (i) the practitioner who is responsible for the care of the newborn, if known; and (ii) if the newborn was born in a facility operated by a local authority or an affiliate, the local authority or affiliate that operates that facility. 8 Aug 2014 cP-37.1 Reg 15 s8; 14 Jly 2023 SR 54/2023 s7. Results to be recorded 9 The written test results provided by a laboratory pursuant to clause 8(b) must be recorded on the health record of the newborn by: (a) the practitioner who received the results; and (b) the local authority or affiliate that received the results. 8 Aug 2014 cP-37.1 Reg 15 s9; 14 Jly 2023 SR 54/2023 s8. PART V Further Tests and Contact by Regional Health Authority Further tests 10 A laboratory shall notify a local authority or an affiliate and the local authority or the affiliate shall take all reasonable steps to contact a parent or guardian of a newborn to collect an additional blood sample from the newborn, if, in the opinion of the laboratory that conducted the tests: (a) the test results are inconclusive; or (b) additional tests are necessary for the purposes of detecting, controlling or preventing a screenable disease. 8 Aug 2014 cP-37.1 Reg 15 s10; 14 Jly 2023 SR 54/2023 s9. Notification to laboratory 11 A local authority shall provide written notice as soon as is practicable to a laboratory if a local authority: (a) is not able to successfully contact a parent or guardian of a newborn pursuant to subsection 6(2) or section 10; or (b) successfully contacts a parent or guardian of a newborn and the parent or guardian has refused to allow a blood sample to be taken. 8 Aug 2014 cP-37.1 Reg 15 s11; 14 Jly 2023 SR 54/2023 s10. 7 NEWBORN SCREENING P-37.1 REG 15 PART VI Disclosure and Request of Information Laboratory may request information 12(1) For the purposes of carrying out its responsibilities pursuant to these regulations, a laboratory may be provided with access to: (a) personal information or personal health information regarding a newborn or a parent or guardian of the newborn from: (i) e-Health Saskatchewan relating to registration information within the meaning of The Health Information Protection Act; and (ii) the local authority or affiliate that operates the facility in which the newborn was born; (b) information regarding registrations of live births from the vital statistics registry maintained pursuant to The Vital Statistics Act, 2009. (2) The information that may be provided pursuant to subsection (1) is limited to the information required by a laboratory to carry out its responsibilities pursuant to these regulations. (3) If, as a result of receiving information pursuant to subsection (1), a laboratory becomes aware that a newborn residing in Saskatchewan has not been tested pursuant to these regulations, the laboratory shall notify the person designated pursuant to subsection 5(2) for the local authority of the jurisdictional area in which: (a) the newborn resides; or (b) the newborn was born. (4) Personal information and personal health information of a newborn and the newborn’s parent or guardian may be disclosed between a laboratory and the local authority or affiliate in whose facility the birth occurred as may be necessary to carry out the newborn screening program. 8 Aug 2014 cP-37.1 Reg 15 s12; 14 Jly 2023 SR 54/2023 s11. PART VII Coming into Force Coming into force 13 These regulations come into force on the day on which they are filed with the Registrar of Regulations. 8 Aug 2014 cP-37.1 Reg 15 s13. 8 P-37.1 REG 15 NEWBORN SCREENING Appendix FORM 1 [Subsection 6(4)] Saskatchewan ______________________________________________________________________________________________________________________________________________________________ Roy Romanow Provincial Laboratory (RRPL) 5 Research Drive Regina, SK Canada S4S 0A4 Refusal of Newborn Screening I, ___________________ , residing at _________________, the ______________________of (name) (place of residence) (parent or guardian) Baby _______________________born _______________ at _______________ (baby’s full name) (date) (location) refuse to have the baby’s blood taken for newborn screening tests for inherited meta- bolic diseases. Baby’s Health Services Number: _____________________________________________ Name of my practitioner: _____________________________________________ I do this with the knowledge that: ● The test requires only a few drops of blood from the baby’s heel. ● These tests are for treatable disorders such as: Phenylketonuria (PKU), congenital hypothyroidism, galactosemia, medium chain Acyl-CoA Dehydrogenase Deficiency (CAD), etc. (For more information, see https://www.saskhealthauthority.ca/facilities- locations/roy-romanow-provincial-laboratory/screening-and-reference-services) ● The baby can appear healthy at birth and still have these diseases. ● These diseases can cause irreversible organ damage to the brain, liver and muscles or death, which may be prevented if treated as soon as possible after birth. ● I understand that it is my sole responsibility to inform the local authority or affiliate of my decision to refuse newborn screening testing by completing and signing this form and submitting it to my practitioner or to the person designated by the local authority as being responsible for the newborn screening program. ● I have made this decision in consultation with my practitioner. Signature of parent/guardian: ___________________________________________________ Date:__________________________________________________________________________ Signature of witness: ___________________________________________________________ Duplicate: One for file; one for practitioner.. 14 Jly 2023 SR 54/2023 s12. REGINA, SASKATCHEWAN Printed by the authority of THE KING’S PRINTER Copyright©2023